NCT04157075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

November 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

November 6, 2019

Last Update Submit

November 7, 2022

Conditions

Pain, PostoperativeOpioid Use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    7 days post-op

  • Time to first bowel movement following uterosacral ligament bupivicaine injection

    7 days post-op

Study Arms (3)

No injection

PLACEBO COMPARATOR

No injection will be performed

Drug: Bupivacaine

Normal Saline Injection

SHAM COMPARATOR

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

Drug: Bupivacaine

Bupivacaine Injection

ACTIVE COMPARATOR

Bupivacaine will be injected into the uterosacral ligaments prior to colpotomy

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Bupivicaine injection into uterosacral ligaments prior to colpotomy

Bupivacaine InjectionNo injectionNormal Saline Injection

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Howard County General Hospital

Columbia, Maryland, 21044, United States

Location

Related Publications (1)

  • Frost AS, Kohn JR, Le Neveu M, Brah T, Okonkwo O, Borahay MA, Wu H, Simpson K, Patzkowsky KE, Wang KC. Laparoscopic administration of bupivacaine at the uterosacral ligaments during benign laparoscopic and robotic hysterectomy: a randomized controlled trial. Am J Obstet Gynecol. 2023 Nov;229(5):526.e1-526.e14. doi: 10.1016/j.ajog.2023.07.047. Epub 2023 Jul 31.

    PMID: 37531986DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Karen Wang

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

March 15, 2021

Primary Completion

October 15, 2022

Study Completion

October 15, 2022

Last Updated

November 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)