Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration

NCT01204892 | Completed

• 1 other identifier: H-27128
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Pain

  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

  24 hours

Secondary Outcomes (2)

• PONV (Postoperative nausea and vomiting)

  24 hours

• Narcotics use

  24 hours

Study Arms (2)

TAP Block

ACTIVE COMPARATOR

Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia

Procedure: TAP Block

Local infiltration

ACTIVE COMPARATOR

20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports

Procedure: Local infiltration

Interventions

TAP Block PROCEDURE

Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia

TAP Block

Local infiltration PROCEDURE

20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports

Local infiltration

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Pregnancy
• Prisoners
• Patient or surgeon refusal

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Jaime Ortiz, MD

  Batylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 12, 2012

Record last verified: 2012-07

Locations

US (1)