Intraperitoneal Infusion of Analgesic for Postoperative Pain Management (ON-Q)

April 3, 2026 updated by: Ying Liu

The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial

The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.

Study Overview

Status

Status

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

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

  • Any patient desiring minimally invasive hysterectomy will be contacted by a study team member during their visit to the MIGS (minimally invasive gynecologic surgery) clinic. The risks and benefits of participation will be explained to them. If they choose to participate they will sign the consent form at that time or if they need more time to consider participation they will sign later. They will then complete the health-related quality of life (HrQoL) questionnaire UFS-QOL* before surgery.
  • Computer-generated randomization will be used to randomize patients between 3 groups:
  • Group A: receiving a continuous infusion of intraperitoneal local anesthetic (LA) during 72 hours
  • Group B: receiving a continuous infusion of intraperitoneal LA combined with an NSAID during 72 hours
  • Group C: receiving a continuous infusion of intraperitoneal placebo during 72 hours.
  • Study participants will then undergo a minimally invasive hysterectomy by one of the highly experienced minimally invasive gynecologists using a standard technique. At the conclusion of the procedure, all women will have an infusion catheter attached to an ON-Q pump inserted percutaneously into the pelvis under direct laparoscopic vision. The catheter tip will be placed in the peritoneal cavity at the vaginal vault. In order to ensure patency of the catheter tubing, a 10 mL bolus of assigned medication will be given. The ON-Q pump infusion will then provide 540 mL of assigned medication for a total of 72 hours following surgery.
  • Surgical variables (length of surgery, estimated blood loss, type of analgesia and anesthesia used, concomitant procedures, uterine weight, ASA, and intraoperative complications - organ injury (bladder, bowel, vaginal laceration), EBL > 1000 cc, conversion to laparotomy, transfusion) will be recorded on a data collection sheet.
  • Additional analgesia will be administered by the nursing staff in the PACU at the patient's request. The total dose of analgesia over the 72 postoperative hours will be calculated for each woman (e.g. each of the following was considered to be one dose; 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol). The total morphine equivalents per patient will also be recorded.
  • All medication administered for pain as well as VAS pain scores at 1, 2, 4, 6, 24, 48, and 72 hours postoperatively will be recorded.
  • Subjects will be discharged when clinically appropriate and according to our usual hospital procedure, which is usually same day discharge. Subjects staying in hospital for less than 72 hours will be given verbal and written instructions on catheter removal.
  • The subjects will be given a post-operative pain diary to fill out during their 2 week recovery period including pain scores and amount of pain medication used. This diary will be collected at their first post-operative visit at around 2 weeks postoperatively. Subjects will be asked to complete the EQ-5D again during this visit. Postoperative complications will also be recorded (ICU-admission, reoperation, transfusion, DVT/PE, readmission, bowel obstruction/ileus, incision seroma/cellulitis/hematoma/separation/hernia, and cuff cellulitis/abscess/dehiscence/granulation tissue).
  • Hospital (operative and pathology reports) and clinical (clinical visit notes) reports will be reviewed to compare baseline demographics, past surgical history, past medical history, comorbidities, and complications between groups.
  • Pumps and syringes will be filled with study drugs depending on the assigned group to a max of 540 mL for pumps and a max of 10 mL for syringes:
  • Group A: receiving a continuous infusion of intraperitoneal local anesthetic (LA) during 72 hours: 10 mL bolus of 0.2% Ropivacaine + 540 mL of 0.2% Ropivacaine at 8 mL/hour infusion
  • Group B: receiving a continuous infusion of intraperitoneal LA combined with an NSAID during 72 hours: 10 mL bolus of 0.2% Ropivacaine combined with 30mg/550mL toradol + 540 mL of 0.2% Ropivacaine combined with 30mg/550mL toradol at 8 mL/hour infusion
  • Group C: receiving a continuous infusion of intraperitoneal placebo during 72 hours: 10 mL bolus of 0.9% normal saline + 540 mL of 0.9% normal saline at 8 mL/hour infusion
  • The IDS research pharmacist will fill the pumps for use and a member of the research team will transport the filled pumps to the hospital for the surgeries.
  • Statistical Analysis: Pre-operative variables such as patient demographic and clinical information (medical and surgical history) will be recorded and compared as well as intra-operative variables such as surgical modality, length of surgery, estimated blood loss, concomitant procedures, uterine weight, ASA, and complications. Before and after their surgery, patients will complete a questionnaire regarding quality of life and pain. To combine the results of both sites, REDCap will be used to securely share de-identified data. These outcome variables will be analyzed by calculating the unadjusted and adjusted means and 95% confidence intervals using simple and multiple linear regressions.

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 (Estimated)

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.
120

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 4

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 Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • James Robinson, MD
      • Washington D.C., District of Columbia, United States, 20037
        • Recruiting
        • The GW Medical Faculty Associates
        • Principal Investigator:
          • Jennifer Keller, MD
        • Contact:

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Hysterectomy planned for a benign gynecologic reason (no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.)
  • Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites.
  • Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH).
  • Patient is capable of informed consent.
  • Patient is capable of completing the questionnaires.

Exclusion Criteria:

  • Concern for malignancy
  • The procedure is scheduled outside MIGS department.
  • Allergy to any study related medication (i.e. Ketorolac and Ropivacaine)
  • Patient is enrolled in another pain management study.

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: Quadruple

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: Ropivacaine
Subjects will receive a continuous intraperitoneal infusion of ropivacaine
Drug: Ropivacaine Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
Other Names:
  • Naropin
Experimental: Ropivacaine + Ketorolac
Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac
Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump
Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
Other Names:
  • Naropin
  • Toradol
Placebo Comparator: Normal Saline
Subjects will receive a continuous intraperitoneal infusion of normal saline
Drug: Normal Saline Infusion from ON-Q Pump
Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
Other Names:
  • Saline solution

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
Pain Level 1 Hour Postoperative
Time Frame: 1 hour postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
1 hour postoperative
Pain Level 2 Hours Postoperative
Time Frame: 2 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
2 hours postoperative
Pain Level 4 Hours Postoperative
Time Frame: 4 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
4 hours postoperative
Pain Level 6 Hours Postoperative
Time Frame: 6 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
6 hours postoperative
Pain Level 24 Hours Postoperative
Time Frame: 24 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
24 hours postoperative
Pain Level 48 Hours Postoperative
Time Frame: 48 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
48 hours postoperative
Pain Level 72 Hours Postoperative
Time Frame: 72 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
72 hours postoperative

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
The total dose of analgesics taken over the 72 postoperative hours
Time Frame: Within 72 hours postoperative
Each of the following was considered to be one dose: 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol
Within 72 hours postoperative

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.
Ying Liu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avanos Medical

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: Jennifer Keller, MD, Physician

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.
September 30, 2019

Primary Completion (Estimated)

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 1, 2026

Study Completion (Estimated)

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.
December 1, 2026

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).
October 16, 2019

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.
October 16, 2019

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.
October 17, 2019

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.
April 9, 2026

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.
April 3, 2026

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.
April 1, 2026

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.
  • 180423

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.

Yes

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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