Pain After Laparoscopic Cholecystectomy With Bilateral Tr... | NCT01204892

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

NCT01204892

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Jul 12, 2012Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

TAP Block
Local infiltration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 16, 2010

First Submission Date that Met QC Criteria

Sep 16, 2010

First Posted Date

Sep 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaime Ortiz, MD	Batylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ben Taub General Hospital		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000772	Anesthesia, Local

Ancestor Terms

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided