Overview

This trial is active, not recruiting.

Condition pain, postoperative
Treatment bupivacaine
Phase phase 1
Sponsor Milton S. Hershey Medical Center
Start date September 2012
End date December 2012
Trial size 140 participants
Trial identifier NCT01688596, 40708

Summary

The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.
(Active Comparator)
The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.
bupivacaine Marcaine
Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.

Primary Outcomes

Measure
Postoperative pain score
time frame: Change from baseline in pain score at 4 hours
Postoperative pain score
time frame: Change from baseline in pain score at 6 hours
Postoperative pain score
time frame: Change from baseline in pain score at 24 hours

Secondary Outcomes

Measure
Estimated Blood Loss
time frame: Measured on day of surgery after procedure completion.
Surgical Complications
time frame: From date of randomization up to 12 months
Operating Time
time frame: Average of 60 minutes
Length of Hospital Stay
time frame: 24 hours
Histopathologic Diagnosis
time frame: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.

Eligibility Criteria

Female participants from 18 years up to 80 years old.

Inclusion Criteria: - Patients who are scheduled for a laparoscopic hysterectomy for benign indications at the Department of Obstetrics & Gynecology's Division of Minimally Invasive Surgery at Milton S. Hershey Medical Center will be included. Exclusion Criteria: - Patients who are scheduled for a hysterectomy through the vaginal or abdominal approach will be excluded. Patients with preoperative indications of endometriosis or chronic pelvic pain will also be excluded since these patients could potentially have higher thresholds of pain.

Additional Information

Official title Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
Principal investigator Maria Teresa Tam, MD
Description The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery. Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.