HysterectomyPhase 4ON-QNCT04130464
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
A Phase 4 study testing Ropivacaine Infusion from ON-Q Pump, Ropivacaine + Ketorolac Infusion from ON-Q Pump and Normal Saline Infusion from ON-Q Pump in people with Hysterectomy and Gynecologic Surgical Procedures, run by Ying Liu at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Gynecologic Surgical Procedures, Narcotic Use
- What is being tested?
- Ropivacaine Infusion from ON-Q Pump, Ropivacaine + Ketorolac Infusion from ON-Q Pump and Normal Saline Infusion from ON-Q Pump
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2019to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
James Robinson, MD, 202-877-0526, james.k.robinson@medstar.net
James Robinson, MD
- Recruiting
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Jennifer Keller, MD, 202 741 2524, jkeller@mfa.gwu.edu
Jennifer Keller, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Ropivacaine Infusion from ON-Q Pump, Ropivacaine + Ketorolac Infusion from ON-Q Pump, Normal Saline Infusion from ON-Q Pump
- Keywords
- Intraperitoneal, Pain Pump, Ropivacaine, Ketorolac Tromethamine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine Infusion from ON-Q PumpDrug
Also called Naropin
Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
Ropivacaine + Ketorolac Infusion from ON-Q PumpDrug
Also called Naropin, Toradol
Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
Normal Saline Infusion from ON-Q PumpDrug
Also called Saline solution
Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Subjects will receive a continuous intraperitoneal infusion of ropivacaine Receives: Drug: Ropivacaine Infusion from ON-Q Pump |
| Ropivacaine + Ketorolac | Experimental | Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac Receives: Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump |
| Normal Saline | Placebo comparator | Subjects will receive a continuous intraperitoneal infusion of normal saline Receives: Drug: Normal Saline Infusion from ON-Q Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level 1 Hour Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 1 hour postoperative
Pain Level 2 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 2 hours postoperative
Pain Level 4 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 4 hours postoperative
Pain Level 6 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 6 hours postoperative
Pain Level 24 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 24 hours postoperative
Pain Level 48 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 48 hours postoperative
Pain Level 72 Hours Postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Measured: 72 hours postoperative
Secondary outcomes (1)
The total dose of analgesics taken over the 72 postoperative hours
Each of the following was considered to be one dose: 1 g of paracetamol, 50 mg diclofenac, 400 mg ibuprofen, 50 mg tramadol
Measured: Within 72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start30 Sep 2019
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Avanos Medical
- Responsible party
- Sponsor-investigator, Ying Liu, George Washington University
- Investigators
- Jennifer Keller, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130464
- Sponsor's protocol ID
- 180423
- Acronym
- ON-Q
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2019
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04130464
- Acronym / sponsor ID
- ON-Q / 180423
- Keywords
- Intraperitoneal, Pain Pump, Ropivacaine, Ketorolac Tromethamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ying LiuUniversity, hospital or other
- Collaborators
- Avanos Medical
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine Infusion from ON-Q PumpSubjects will receive a continuous intraperitoneal infusion of ropivacaine |
| Ropivacaine + Ketorolac | Experimental | Drug: Ropivacaine + Ketorolac Infusion from ON-Q PumpSubjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac |
| Normal Saline | Placebo comparator | Drug: Normal Saline Infusion from ON-Q PumpSubjects will receive a continuous intraperitoneal infusion of normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine Infusion from ON-Q PumpAlso: NaropinInfusion of 0.2% ropivacaine at 8 mL/hour for 72 hours | Drug | Ropivacaine |
| Ropivacaine + Ketorolac Infusion from ON-Q PumpAlso: Naropin, ToradolInfusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours | Drug | Ropivacaine + Ketorolac |
| Normal Saline Infusion from ON-Q PumpAlso: Saline solutionInfusion of 0.9% normal saline at 8 mL/hour for 72 hours | Drug | Normal Saline |
Primary outcome
Pain Level 1 Hour Postoperative
Time frame: 1 hour postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 2 Hours Postoperative
Time frame: 2 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 4 Hours Postoperative
Time frame: 4 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 6 Hours Postoperative
Time frame: 6 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 24 Hours Postoperative
Time frame: 24 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 48 Hours Postoperative
Time frame: 48 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
Pain Level 72 Hours Postoperative
Time frame: 72 hours postoperative
Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"
1 secondary outcome
The total dose of analgesics taken over the 72 postoperative hours
Time frame: Within 72 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Keller, MD principal investigator
Physician
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine Infusion from ON-Q Pump, Ropivacaine + Ketorolac Infusion from ON-Q Pump and Normal Saline Infusion from ON-Q Pump in people with Hysterectomy and Gynecologic Surgical Procedures, run by Ying Liu at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radwa Aly (202 677 6209, raly@mfa.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level 1 Hour Postoperative (time frame: 1 hour postoperative). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.