Marcaine Use in Laparoscopic Gynecological Surgery
Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-operative Pain
Intervention: Marcaine- 0.25% (Drug); Marcaine 0.25%. (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Weill Medical College of Cornell University Official(s) and/or principal investigator(s):
Glenn Schattman, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell
Summary
The purpose of this trial is to compare incisional pain in patients receiving pre-incisional
versus post operative Marcaine injection.
Clinical Details
Official title: A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Pain level.
Secondary outcome: Use of pain medication
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Weill Cornell Medical College, New York, New York 10021, United States
Additional Information
Starting date: June 2010
Last updated: January 6, 2014
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