ON-Q: Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

Sponsor

George Washington University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04130464

Collaborator

Avanos Medical (Other)

120

Enrollment

Locations

Arms

59.1

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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 (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy Gynecologic Surgical Procedures Narcotic Use Pain, Postoperative	Drug: Ropivacaine Infusion from ON-Q Pump Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump Drug: Normal Saline Infusion from ON-Q Pump	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This is a double-blind study; the surgeon and the patient will not know which study group they are a part of. Only the IDS pharmacist and IDS pharmacy technician will know which group each study patient has been assigned to.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The total dose of analgesics taken over the 72 postoperative hours [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
2	The GW Medical Faculty Associates	Washington	District of Columbia	United States	20037