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
About this trial
This is an interventional treatment trial for Post-operative Pain
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
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
NCT ID
NCT01861665
First Posted
May 21, 2013
Last Updated
October 10, 2018
Sponsor
Weill Medical College of Cornell University
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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