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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)
Masking Description
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

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
No injection 		No injection will be performed
  • Drug: Bupivacaine
    Bupivicaine injection into uterosacral ligaments prior to colpotomy
Sham Comparator
Normal Saline Injection 		Normal saline will be injected into the uterosacral ligaments prior to colpotomy
  • Drug: Bupivacaine
    Bupivicaine injection into uterosacral ligaments prior to colpotomy
Active Comparator
Bupivacaine Injection 		Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy
  • Drug: Bupivacaine
    Bupivicaine injection into uterosacral ligaments prior to colpotomy

More Details

Status
Completed
Sponsor
Johns Hopkins University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.