Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Johns Hopkins University

Status and phase: Completed; Early Phase 1

Conditions: Pain, Postoperative; Opioid Use

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04157075

IRB00221267

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups, including a placebo group

No injection

Placebo Comparator group

Description:

No injection will be performed

Treatment:

Drug: Bupivacaine

Normal Saline Injection

Sham Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Bupivacaine Injection

Active Comparator group

Description:

Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy

Treatment:

Drug: Bupivacaine