Marcaine Use in Laparoscopic Gynecological Surgery

NCT ID: NCT01861665

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2017-01-31

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Marcaine administered pre-incision.

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

Group Type: ACTIVE_COMPARATOR

Marcaine- 0.25%

Intervention Type: DRUG

Marcaine 0.25% administered pre-incision.

Marcaine administered post-incision

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

Group Type: ACTIVE_COMPARATOR

Marcaine 0.25%.

Intervention Type: DRUG

Marcaine 0.25% administered post-incision.

Interventions

Marcaine- 0.25%

Marcaine 0.25% administered pre-incision.

Intervention Type: DRUG

Marcaine 0.25%.

Marcaine 0.25% administered post-incision.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Schattman, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

1004010977

Identifier Type: -

Identifier Source: org_study_id