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Completed

NCT Number: NCT04157075

Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine

Drug

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Primary outcomes

  1. Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection

    Time frame: 7 days post-op

    Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference

Secondary outcomes

  1. Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection

    Time frame: 7 days post-op

    Patient will report VAS scores daily until post-op day 7 on a scale of 1-10 with higher scores indicating higher pain severity. The investigators will be looking for a statistically significant difference between the treatment and placebo vs. sham group.

  2. Time to first bowel movement following uterosacral ligament bupivicaine injection

    Time frame: 7 days post-op

    Patients will record when they resume normal bowel function on a pill diary post-operatively

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2019
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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