Marcaine Use in Laparoscopic Gynecological Surgery

Post-operative Pain Clinical Trial

— Marcaine  

Official title:

A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861665
• Other study ID #: 1004010977
• Status: Terminated
• Phase: N/A
• Start date: June 2010
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to compare incisional pain in patients receiving pre-incisional versus post operative Marcaine injection.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Marcaine- 0.25%
Marcaine 0.25% administered pre-incision.
• Marcaine 0.25%.
Marcaine 0.25% administered post-incision.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, 2

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post surgery day 0, post surgery day 1, post surgery day 2