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Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

Primary Purpose

Pain, Postoperative, Opioid Use

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Johns Hopkins Hospital
  • Howard County General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Sham Comparator

Active Comparator

Arm Label

No injection

Normal Saline Injection

Bupivacaine Injection

Arm Description

No injection will be performed

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

Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
November 6, 2019
Last Updated
November 7, 2022
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04157075
Brief Title
Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy
Official Title
The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
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
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No injection
Arm Type
Placebo Comparator
Arm Description
No injection will be performed
Arm Title
Normal Saline Injection
Arm Type
Sham Comparator
Arm Description
Normal saline will be injected into the uterosacral ligaments prior to colpotomy
Arm Title
Bupivacaine Injection
Arm Type
Active Comparator
Arm Description
Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivicaine injection into uterosacral ligaments prior to colpotomy
Primary Outcome Measure Information:
Title
Difference in post-operative opioid usage with the use of uterosacral ligament bupivacaine injection
Description
Total morphine equivalents of opioids in the first 7 days after surgery will be assessed to look for a statistically significant difference
Time Frame
7 days post-op
Secondary Outcome Measure Information:
Title
Difference in Visual analog scores (VAS) scores following uterosacral ligament bupivicaine injection
Description
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 Frame
7 days post-op
Title
Time to first bowel movement following uterosacral ligament bupivicaine injection
Description
Patients will record when they resume normal bowel function on a pill diary post-operatively
Time Frame
7 days post-op

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Wang
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Howard County General Hospital
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy

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