Marcaine Use in Laparoscopic Gynecological Surgery

Not Applicable

Terminated

• Conditions: Post-operative Pain
• Interventions: Drug: Marcaine- 0.25%; Drug: Marcaine 0.25%.

• Registration Number: NCT01861665
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2017-10-25
• Results First Submitted QC: 2018-03-19
• Results First Posted: 2018-03-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Marcaine administered pre-incision.	Marcaine- 0.25%	Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision.
Marcaine administered post-incision	Marcaine 0.25%.	Marcaine 0.25% administered post-incision, total amount 5cc per incision.

Primary Outcome Measures

Name	Time	Method
Wong-Baker Faces Pain Rating Scale	Post surgery day 0, post surgery day 1, post surgery day 2	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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States