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Clinical Trials/NCT01204892
NCT01204892
Completed
Not Applicable

Postoperative Pain After Laparoscopic Cholecystectomy in Patients Receiving Bilateral Ultrasound-guided Transverse Abdominis Plane Block Compared With Local Anesthetic Infiltration of Trochar Insertion Sites With Ropivacaine 0.5%

Baylor College of Medicine1 site in 1 country80 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Baylor College of Medicine
Enrollment
80
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Detailed Description

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy. Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
May 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaime Ortiz

Assistant Professor of Anesthesiology

Baylor College of Medicine

Eligibility Criteria

Inclusion Criteria

  • Patient ages 18-64
  • American Society of Anesthesiology Physical Status I, II or III
  • Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria

  • Open cholecystectomy - excluded due to increased levels of pain in open procedures
  • Scheduled for ambulatory surgery
  • Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  • Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
  • Allergy or contraindication to any of the study medications or anesthetic agents
  • Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  • Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  • Patient or surgeon refusal

Outcomes

Primary Outcomes

Pain

Time Frame: 24 hours

Pain scores on NAS scale (0-10) at the following times: Preop, Time 0, Time 1, Time 2, Time 4, Time 8, Time 12, Time 24

Secondary Outcomes

  • Narcotics use(24 hours)
  • PONV (Postoperative nausea and vomiting)(24 hours)

Study Sites (1)

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