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Marcaine Use in Laparoscopic Gynecological Surgery (Marcaine)

Primary Purpose

Post-operative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marcaine- 0.25%
Marcaine 0.25%.
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • • Ages 18-50

    • BMI 20-35
    • Gynecologic ambulatory cases only
    • Total of 3 incisions, with left and right incisions both being 5mm-10mm in size
    • Not taking pain medications prior to surgery
    • Length of surgery up to 3 hours
    • PACU stay up to 6 hours
    • Willing and able to sign informed consent

Exclusion Criteria:

  • • Age or BMI out of range

    • Surgery longer than 3 hours or PACU stay longer than 6 hours
    • patients with chronic pelvic pain
    • Oncologic cases
    • Pregnant patients

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Marcaine administered pre-incision.

Marcaine administered post-incision

Arm Description

Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.

Marcaine 0.25% administered post-incision, total amount 5cc per incision.

Outcomes

Primary Outcome Measures

Wong-Baker Faces Pain Rating Scale
Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2013
Last Updated
October 10, 2018
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01861665
Brief Title
Marcaine Use in Laparoscopic Gynecological Surgery
Acronym
Marcaine
Official Title
A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator no longer recruiting subjects.
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.
Detailed Description
Post-operative pain control is a key component of a patient's experience with surgery. In laparoscopic surgery, small (5 to 12mm) incisions are made, usually at the umbilicus and/on at either side of the lower abdomen, to allow insertion of a laparoscopic camera ("scope") and various laparoscopic instruments. The advantages for the patient of this approach compared to conventional open surgery include faster recovery with a significantly shorter hospital stay, less pain and less requirements for pain medication with a better cosmetic outcome. In many cases, the patient will go home within 24 hours of surgery. Many laparoscopic surgeons administer local anesthesia at the incision sites to assist in post-operative pain control. The best method for administration of the local anesthetic for optimal pain relief remains unclear. Some research has demonstrated that perhaps preemptive administration of local anesthetic improves post-operative pain control although in these studies, differences in patient populations and perception of pain between different patients makes comparison difficult. Optimizing analgesia protocols would benefit patients resulting in better pain relief and less use of narcotic analgesics with their associated side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marcaine administered pre-incision.
Arm Type
Active Comparator
Arm Description
Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.
Arm Title
Marcaine administered post-incision
Arm Type
Active Comparator
Arm Description
Marcaine 0.25% administered post-incision, total amount 5cc per incision.
Intervention Type
Drug
Intervention Name(s)
Marcaine- 0.25%
Intervention Description
Marcaine 0.25% administered pre-incision.
Intervention Type
Drug
Intervention Name(s)
Marcaine 0.25%.
Intervention Description
Marcaine 0.25% administered post-incision.
Primary Outcome Measure Information:
Title
Wong-Baker Faces Pain Rating Scale
Description
Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.
Time Frame
Post surgery day 0, post surgery day 1, post surgery day 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Ages 18-50 BMI 20-35 Gynecologic ambulatory cases only Total of 3 incisions, with left and right incisions both being 5mm-10mm in size Not taking pain medications prior to surgery Length of surgery up to 3 hours PACU stay up to 6 hours Willing and able to sign informed consent Exclusion Criteria: • Age or BMI out of range Surgery longer than 3 hours or PACU stay longer than 6 hours patients with chronic pelvic pain Oncologic cases Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Schattman, MD
Organizational Affiliation
Weill Medical College of Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Singer T, Huang JY, Schattman GL, Joseph M, Stubbs RE, Rosenwaks Z. RCT- Comparing Bupivicaine Adminstration in Laparoscopic Gynecologic Surgery Using Either a Pre-Incision or Post-Closure Injection. Journal of Minimally Invasive Gynecology 19 (6): S46, 2012.
Results Reference
result

Learn more about this trial

Marcaine Use in Laparoscopic Gynecological Surgery

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