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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01204892
First received: September 16, 2010
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Procedure: TAP Block
Procedure: Local infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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%

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • PONV (Postoperative nausea and vomiting) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    PONV events in first 24 hours

  • Narcotics use [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Fentanyl, morphine, and hydrocodone/apap total for 24 hours


Enrollment: 80
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAP Block
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
Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
Active Comparator: Local infiltration
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
  2. Scheduled for ambulatory surgery
  3. Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
  4. Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
  5. Allergy or contraindication to any of the study medications or anesthetic agents
  6. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
  7. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
  8. Pregnancy
  9. Prisoners
  10. Patient or surgeon refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204892

Locations
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Jaime Ortiz, MD Batylor College of Medicine
  More Information

No publications provided

Responsible Party: Jaime Ortiz, Assistant Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01204892     History of Changes
Other Study ID Numbers: H-27128
Study First Received: September 16, 2010
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Ropivacaine
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013