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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAP Block
Local infiltration
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ben Taub General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAP Block

Local infiltration

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PONV (Postoperative nausea and vomiting)
PONV events in first 24 hours
Narcotics use
Fentanyl, morphine, and hydrocodone/apap total for 24 hours

Full Information

First Posted
September 16, 2010
Last Updated
July 11, 2012
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01204892
Brief Title
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration
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%
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block
Arm Type
Active Comparator
Arm Description
Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
Arm Title
Local infiltration
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Intervention Description
Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Local infiltration
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
PONV (Postoperative nausea and vomiting)
Description
PONV events in first 24 hours
Time Frame
24 hours
Title
Narcotics use
Description
Fentanyl, morphine, and hydrocodone/apap total for 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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) Pregnancy Prisoners Patient or surgeon refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ortiz, MD
Organizational Affiliation
Batylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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