Marcaine Use in Laparoscopic Gynecological Surgery

NCT01861665 | Terminated Results

• 1 other identifier: 1004010977
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Marcaine administered pre-incision.

ACTIVE COMPARATOR

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

Drug: Marcaine- 0.25%

Marcaine administered post-incision

ACTIVE COMPARATOR

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

Drug: Marcaine 0.25%.

Interventions

Marcaine 0.25%. DRUG

Marcaine 0.25% administered post-incision.

Marcaine administered post-incision

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related 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, 2012.

  RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Glenn Schattman, Associate Professor
• Organization: Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine.

glschatt@med.cornell.edu

646-962-3836

Study Officials

• Glenn Schattman, MD

  Weill Medical College of Cornell

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.

Study Record Dates

• First Submitted: May 21, 2013
• First Posted: May 23, 2013
• Study Start: June 1, 2010
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 12, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-10

Locations

US (1)