Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

May 11, 2023 updated by: Silpa Nekkanti, Ohio State University

Randomized Controlled Trial of a Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery. The study will include women >/= 18yo who speak English and are admitted for observation after a qualifying laparoscopic or robotic gynecologic procedure. The investigators will identify potential participants from the operating schedule, screen for any exclusion criteria, and approach those eligible for inclusion on the day of surgery. All participants will receive a pain regimen with medications commonly used to manage post-surgical pain including nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and prescription opioids. Participants randomized to the intervention arm will receive prolonged scheduled NSAID and acetaminophen (96 hours instead of 24 hours) and will receive 24 hours of intermittent ice-therapy (20 minutes every 2-3 hours) on their abdominal incisions beginning within 1-2 hours after surgery. On post-operative day or day 1, a study investigator will administer a study questionnaire to all participants which will include a pain score, satisfaction score, and quality of recovery validated survey (the QoR-40). After discharge, participants will complete short web-based survey questionnaires on day 2 and 3. On day 4 a final and more comprehensive web-based survey will be sent to all participants which will include the 24-hour assessment in addition to the QoR-40 questionnaire, a final satisfaction questionnaire, and pill counts of left-over discharge medications. The day 4 survey completes the participants active part in the study. On or after day 30 a chart review will be performed to assess for post-operative complications, emergency room visits, telephone calls, unexpected office visits, and refill requests. An Ohio Rx Reporting System (OARRS) report will further screen for any additional narcotic prescriptions in the 30 day postoperative period. This will mark completion of participation in study. The completion of the study questionnaires is anticipated to take about 1.5 to 2 hours in total time throughout the study. There are no additional clinic visits or costs associated with participation in this study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Minimally invasive (laparoscopic or robotic) major gynecologic procedures including: pelvic floor procedures (uterosacral ligament suspension, sacrocolpopexy, Burch colposuspension) with or without concomitant hysterectomy, adnexal surgery, or vaginal surgery; total or supracervical hysterectomy with or without concomitant adnexal surgery, vaginal surgery, or other minor gynecologic procedures
  • Patients admitted to the hospital for at least an overnight observation after their surgery
  • English-speaking
  • Surgery being performed by one of the five attending surgeons included in study

Exclusion Criteria:

  • Pregnancy. If patient is of childbearing potential and not using contraception a urine pregnancy test will be completed as part of standard practice as part of pre-operative labs.
  • Diagnosis of chronic pelvic pain. Documented pelvic pain noted to be of >6 months duration.
  • Diagnosis or history of chronic opioid use. Defined as use of opioids most days, for more than 3 months.
  • Diagnosis or history of opioid abuse disorder.
  • Current daily opioid use.
  • Liver, renal, or cardiac disease that is/are a contraindication to any medications used in the study.
  • Allergy or intolerance to any medication used in the study (with exception of oxycodone which can be substituted for hydromorphone if necessary).
  • Dementia or inability to understand or respond to the study measurement tools.
  • Intraoperative exclusion criteria (to be reviewed after surgery is complete): conversion to total vaginal procedure or laparotomy, major intraoperative complications that would deem participant inappropriate for trial (hemorrhage, blood transfusion, conversion to laparotomy, bowel surgery, major urologic procedures including bladder or ureteral repair).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Novel multimodal protocol group
They will receive scheduled topical ice therapy for 24 hours after surgery. It will be applied over abdominal incisions for 20 minutes every 2-3 hours. Acetaminophen and an NSAID will be scheduled for 96 hours. While inpatient, they will receive acetaminophen 975 mg every 8 hours and IV Toradol 15-30 mg every 6 hours with change to ibuprofen 800 mg every 8 hours when tolerating oral intake. They may take oxycodone 5 mg every 4-6 hours as needed (PRN) for breakthrough pain and pain score >6. They may use ice PRN after 24 hours. They will be prescribed acetaminophen 1000 mg every 8 hours and ibuprofen 800 mg every 8 hours for 96 hours postoperative. They may take them as needed after. If the participant used 0 narcotics in the first 24 hours, they will not be prescribed a narcotic. If up to 5 tablets were used, they will be prescribed 5 tablets of oxycodone 5 mg every 6 hours PRN. If more than 5 tablets were used, they will be prescribed 10 tablets of oxycodone 5 mg every 6 hours PRN.
Other: Opioid-sparing multimodal pain management
Ice pack applied to abdominal incisions for 20 minutes every 2 to 3 hours for 24 hours after surgery and scheduled acetaminophen and NSAID for 96 hours after surgery. Narcotic pain medication for severe breakthrough pain.
Other Names:
  • Cryotherapy
  • Ice therapy
  • Ice pack
Active Comparator: Usual care protocol group
Participants randomly assigned to the usual care protocol will receive current standard of care: scheduled acetaminophen and an NSAID for 24 hours. They will take acetaminophen 975 mg every 8 hours. They will also receive IV toradol 15 to 30 mg every 6 hours then switch to ibuprofen 800 mg every 8 hours when tolerating oral intake. They can also take oxycodone 5 mg every 4 to 6 hours on an as needed (PRN) basis for breakthrough pain with a pain score >6. Per our current standard of care, usual care participants will be allowed to use either topical heat or ice on an as needed basis during their recovery. On discharge home, they will be prescribed acetaminophen 1000 mg every 8 hours PRN and ibuprofen 800 mg every 8 hours PRN. They will also be prescribed 15 tablets of oxycodone 5 mg every 6 hours PRN.
Other: Usual care
Scheduled acetaminophen and NSAID for 24 hours after surgery. Narcotic pain medication for severe breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Day 1 pain score assessed by NRS-11
Time Frame: During the intervention on postoperative day 1 between 0600 to 0900
Postoperative day 1 or Day 1 pain score will be measured using a commonly used and validated 11-point numerical rating scale (NRS-11) for pain intensity the morning after surgery between 0600 to 0900. The patient will be prompted to evaluate their current pain at rest. A score of zero will correspond with "no pain" and a score of 10 corresponds with "worst possible pain." The outcome will be recorded directly into their Day 1 study survey in REDCap.
During the intervention on postoperative day 1 between 0600 to 0900

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Day 2 to 4 pain score assessed by NRS-11
Time Frame: During the intervention on postoperative day 2 to 4
Pain scores on Day 2, 3, and 4: An NRS-11 pain score at rest will be collected on Day 2, 3, and 4 via electronic REDCap survey. A score of zero will correspond with "no pain" and a score of 10 corresponds with "worst possible pain."
During the intervention on postoperative day 2 to 4
Quality of Recovery assessed by QoR-40
Time Frame: During the intervention on postoperative day 1 and 4
Participants will be asked to complete a validated quality of recovery questionnaire (the QoR-40) on Day 1 in AM as part of their Day 1 study survey that will be administered electronically directly into REDCap. The QoR-40 will also be administered on Day 4 via electronic REDCap survey. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
During the intervention on postoperative day 1 and 4
Patient satisfaction with pain control assessed by NRS-11
Time Frame: During the intervention on postoperative day 1 and 4
Participants will be asked to rate their post-operative pain control satisfaction using an NRS-11 scale for satisfaction. The question prompt on Day 1 will read "On a scale of 0 to 10 how would you rate your satisfaction with your postoperative pain control in the last 24 hours?" A score of 0 corresponds with "very dissatisfied" and a score of 10 corresponds with "very satisfied." A pain control satisfaction NRS-11 will also be administered on Day 4 as part of the electronic REDCap survey. The question prompt on Day 4 will read "On a scale of 0 to 10 how would you rate your satisfaction with your postoperative pain control since you left the hospital?"
During the intervention on postoperative day 1 and 4
Patient satisfaction with ice therapy assessed by NRS-11
Time Frame: During the intervention on postoperative day 1 and 4
Patient satisfaction with the scheduled 24 hour ice therapy will be assessed using the same NRS-11 satisfaction scale as described above. Ice therapy satisfaction will be assessed on Day 1 as part of the Day 1 AM REDCap survey to be administered electronically directly into REDCap. The question prompt with the NRS-11 will read "On a scale from 0 to 10, how would you rate your satisfaction with the ice therapy as part of your postoperative pain regimen?" A score of 0 corresponds with "very dissatisfied" and a score of 10 corresponds with "very satisfied." We will also ask the following non-validated questions aimed at assessing patient satisfaction with their ice therapy: "Did you feel that the ice therapy was helpful? Did you feel that the ice therapy was bothersome? If you had to do it over, would you use the ice therapy again?" These same questions will be administered as part of the Day 4 electronic REDCap survey.
During the intervention on postoperative day 1 and 4
Patient satisfaction with ice therapy assessed by brief questionnaire
Time Frame: During the intervention on postoperative day 1 and 4
Patient satisfaction with the scheduled 24 hour ice therapy will also be assessed by asking a brief questionnaire including the following non-validated questions: "Did you feel that the ice therapy was helpful? Did you feel that the ice therapy was bothersome? If you had to do it over, would you use the ice therapy again?" The answer options will be "yes" or "no". These same questions will be administered as part of the Day 4 electronic REDCap survey.
During the intervention on postoperative day 1 and 4
Analgesic use - opioids measured by morphine equivalents
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of any opioids will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Any use of intravenous opioids will be specifically noted in study database. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will have fields for frequency and dosage in milligrams of opioid use over the past 24 hours. All opioid information will be converted into oral morphine equivalents using an equianalgesic dosage conversion calculator.
Immediately after the surgery from postoperative day 0 to 4
Analgesic use frequency - acetaminophen
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of acetaminophen will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will have a field for frequency of acetaminophen use with the ability to select from the following options: "every 4 hours, every 6 hours, every 8 hours, twice a day, once a day, or other".
Immediately after the surgery from postoperative day 0 to 4
Analgesic use dosage - acetaminophen measured by milligrams
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of acetaminophen will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will ask dosage of acetaminophen use measured in milligrams over the past 24 hours.
Immediately after the surgery from postoperative day 0 to 4
Analgesic use frequency - NSAID
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of any NSAID will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will have a field for frequency of NSAID use with the ability to select from the following options: "every 4 hours, every 6 hours, every 8 hours, twice a day, once a day, or other".
Immediately after the surgery from postoperative day 0 to 4
Analgesic use dosage - NSAID measured by milligrams
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of any NSAID will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will ask dosage of NSAID use measured in milligrams over the past 24 hours.
Immediately after the surgery from postoperative day 0 to 4
Analgesic use - other neuraxial agent
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of any other neuraxial agent or medication for pain (i.e. gabapentin) will be extracted from the medical record and recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will have a "free text" field to allow the participant to describe any use of a medication for pain not listed above.
Immediately after the surgery from postoperative day 0 to 4
Ice therapy use frequency
Time Frame: Immediately after the surgery from postoperative day 0 to 4
Administration or use of ice therapy will be extracted from the nurse ice administration logs. This will be recorded in the study database for the pre-operative, intraoperative, immediate post-operative (i.e. PACU), and inpatient time points. Once discharged from the hospital, participants will be asked to fill out a daily pain control and medication use electronic survey on Day 2, 3, and 4. The brief survey will have fields for frequency of ice therapy with the ability to select from the following options: "every 1-2 hours, every 2-3 hours, every 3-4 hours, every 4-5 hours, every 5-6 hours, every 6-8 hours, every 8-12 hours, or once".
Immediately after the surgery from postoperative day 0 to 4
30-day postoperative outcomes
Time Frame: After the surgery on postoperative day 1 to 30
After Day 30, a study investigator will perform a chart review and an OARRS (Ohio automated Rx reporting system) report on each participant in order to complete the secondary outcomes of 30-day post-operative complications, unexpected office phone calls or visits, emergency room visits, readmissions, and medication refill requests.
After the surgery on postoperative day 1 to 30
Adverse events (AEs)
Time Frame: During the intervention on postoperative day 1 to 4
Throughout the study we will monitor for AEs, both anticipated and unanticipated. Possible AEs for scheduled ice therapy could include local discomfort, skin irritation, or ice burn if used incorrectly without a barrier between ice therapy and skin. Ice therapy side effects or AEs will be directly queried on Day 1 by study investigator, and on Day 2, 3, and 4 via electronic survey. All AEs will be reported to The Ohio State IRB according to the reporting guidelines. AEs will be assessed at each clinical/research visit and reported with study outcomes.
During the intervention on postoperative day 1 to 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silpa Nekkanti, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020H0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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