Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy (RA-TLH)

July 28, 2023 updated by: Sarah Andres, D.O., State University of New York at Buffalo
Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.

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

Material and Methods:

This is a prospective cohort study with historical controls. Cases of those receiving a non-opioid multimodal pain regimen will be compared to historical controls of those receiving a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325 grams will be included in this study. Multimodal pain regimen will include the following:

Protocol:

Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area)

  • Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area)

Intra-Op:

  • Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
  • Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
  • Will operate at <15mmHg intra-abdominal pressure with goal of <12mmHg
  • At end of procedure during closure of fascia, give 30mg ketorolac IV x 1

Post-Op:

  • Gabapentin 300mg PO BID for 7 days
  • Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
  • Celecoxib 200mg PO q 12h x 7d
  • Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME)
  • if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
  • Also include standard post-op medications such as zofran, reglan, mylicon…

Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes include pain scores as rated subjectively by the patient, length of stay in hours and whether the patient returns to the clinic or emergency department due to post operative pain within a 2 week period.

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.
68

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.
  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Williamsville, New York, United States, 14221
        • Millard Fillmore Suburban Hospital

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

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy
  • Uterine weight ≤325 grams

Exclusion Criteria:

  • contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)
  • current opioid prescription

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: Non-Randomized
  • Interventional Model: Sequential 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: Prospective cohort

Pre-Op:

  • Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
  • Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)

Intra-Op:

  • Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
  • Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
  • Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
  • At end of procedure during closure of fascia, give 30mg ketorolac IV x 1

Post-Op:

  • Gabapentin 300mg PO BID for 7 days
  • Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
  • Celecoxib 200mg PO q 12h x 7d
  • Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
Drug: Gabapentin
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
Drug: Acetaminophen
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
Other Names:
  • Tylenol
Drug: Celecoxib
Celecoxib 200mg PO q 12h x 7d post op
Other Names:
  • Celebrex
Drug: Ketorolac
30mg IV once at end of hysterectomy procedure
Other Names:
  • Toradol
Procedure: Paracervical block with ropivacaine
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
Procedure: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
Drug: Hydromorphone
1mg IV PRN q3h, post op, while inpatient
Other Names:
  • Dilaudid
Drug: Oxycodone
To be discharged home with: 12 tabs of 5mg PRN q4h
Active Comparator: Historical Control
Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
Drug: Hydromorphone
1mg IV PRN q3h, post op, while inpatient
Other Names:
  • Dilaudid

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
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
Time Frame: 0-3 hours after surgery
Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
0-3 hours after surgery
Total Opioid Pain Medications Required Through 3-24h Post op in MME
Time Frame: 3-24 hours after surgery
Total opioid pain medications required through 3-24h post op in MME
3-24 hours after surgery

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
Pain Scores
Time Frame: 3-24 hours after surgery
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
3-24 hours after surgery
Pain Scores
Time Frame: 0-3 hours after surgery
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
0-3 hours after surgery
Length of Stay in Hours
Time Frame: 0- 240 hours
Length of stay in hours
0- 240 hours
Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
Time Frame: 0-14 days
Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period
0-14 days
Operative Time
Time Frame: 0-300 minutes
minutes
0-300 minutes
Estimated Blood Loss
Time Frame: 0-300 minutes
milliliters (mL)
0-300 minutes

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.
State University of New York at Buffalo

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: Sarah Andres, D.O., University at Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 24, 2020

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.
May 31, 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.
May 31, 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).
April 28, 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.
June 10, 2020

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.
June 11, 2020

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.
August 1, 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.
July 28, 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.
July 1, 2023

More Information

Terms related to this study

Keywords

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.
  • STUDY00004549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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