Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-10-15

Brief Summary

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This is proof of concept, phase I randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. Patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.

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Detailed Description

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Conditions

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Pain, Postoperative Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Patients will be blinded to which arm they are in, surgeon will not as they will be performing injection however will not be assessing pain scores

Study Groups

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No injection

No injection will be performed

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Normal Saline Injection

Normal saline will be injected into the uterosacral ligaments prior to colpotomy

Group Type SHAM_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Bupivacaine Injection

Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Interventions

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Bupivacaine

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women over the age of 18 years old
* undergoing benign minimally invasive hysterectomy with minimally invasive GYN surgeon at Johns Hopkins Hospital
* Patients must be English speaking.

Exclusion Criteria

* Pregnancy
* allergy, contraindication, or intolerance to bupivacaine, opioids, Tylenol, or NSAID drugs
* pre-operative daily opioid consumption
* peri-operative transverse abdominis plane block
* recent history of drug or alcohol abuse (in last year)
* severe cardiovascular, hepatic or renal disease.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes