Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157075
• Other study ID #: IRB00221267
• Status: Completed
• Phase: Early Phase 1
• Start date: March 15, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: March 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
Bupivicaine injection into uterosacral ligaments prior to colpotomy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Howard County General Hospital	Columbia	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection	Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference	7 days post-op
Secondary	Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection	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.	7 days post-op
Secondary	Time to first bowel movement following uterosacral ligament bupivicaine injection	Patients will record when they resume normal bowel function on a pill diary post-operatively	7 days post-op