Marcaine Use in Laparoscopic Gynecological Surgery

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

Detailed Description
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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.

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

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Marcaine- 0.25%
* Drug: Marcaine 0.25%.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients are acting as their own control receiving Bupivicaine (Marcaine) on both sides. One arm is pre incision the other arm is post incision.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marcaine administered pre-incision.<br>Pre-operative administration, using both the specific drug - Marcaine 0.25%- and total amount - 5cc per incision. | Drug: Marcaine- 0.25%<br>* Marcaine 0.25% administered pre-incision.<br>|
| Active Comparator: Marcaine administered post-incision<br>Marcaine 0.25% administered post-incision, total amount 5cc per incision. | Drug: Marcaine 0.25%.<br>* Marcaine 0.25% administered post-incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |