Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04157075

Collaborator

(none)

180

Enrollment

Locations

Arms

22.6

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Opioid Use	Drug: Bupivacaine	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection [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 Outcome Measures

Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection [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.
Time to first bowel movement following uterosacral ligament bupivicaine injection [7 days post-op]
Patients will record when they resume normal bowel function on a pill diary post-operatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
2	Howard County General Hospital	Columbia	Maryland	United States	21044

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Karen Wang, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT04157075

Other Study ID Numbers:

IRB00221267

First Posted:

Nov 8, 2019

Last Update Posted:

Jul 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jul 22, 2022