Clinical trial

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

Name

180423

Description

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.

Trial arms

Trial start

2019-09-30

Estimated PCD

2024-09-01

Trial end

2024-09-01

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine Infusion from ON-Q Pump

Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours

Arms:

Ropivacaine

Other names:

Naropin

Ropivacaine + Ketorolac Infusion from ON-Q Pump

Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours

Arms:

Ropivacaine + Ketorolac

Other names:

Naropin, Toradol

Normal Saline Infusion from ON-Q Pump

Infusion of 0.9% normal saline at 8 mL/hour for 72 hours

Arms:

Normal Saline

Other names:

Saline solution

Size

120

Primary endpoint

Pain Level 1 Hour Postoperative

1 hour postoperative

Pain Level 2 Hours Postoperative

2 hours postoperative

Pain Level 4 Hours Postoperative

4 hours postoperative

Pain Level 6 Hours Postoperative

6 hours postoperative

Pain Level 24 Hours Postoperative

24 hours postoperative

Pain Level 48 Hours Postoperative

48 hours postoperative

Pain Level 72 Hours Postoperative

72 hours postoperative

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-11-08

1 organization

3 products

5 indications

Organization

Ying Liu

Product

Ropivacaine

Indication

Hysterectomy

Indication