Clinical trial NCT01861665: Marcaine Use in Laparoscopic Gynecological Surgery
Official title: A Comparative Trial of Marcaine Administration in Laparoscopic Gynecologic Surgery Using Either a Pre- or Post-operative Injection.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: Post surgery day 0, post surgery day 1, post surgery day 2
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell
name: Glenn Schattman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.