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Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

NCT ID: NCT01595165

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

Brief Summary

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Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Postoperative Pain Abdominal Muscles Nerve Block

Keywords

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laparoscopic cholecystectomy ultrasound transversus abdominis plane block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Control group receiving saline instead of ropivacaine

Group Type PLACEBO_COMPARATOR

Placebo Ultrasound guided subcostal TAP block

Intervention Type PROCEDURE

Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.

TAP

TAP group receiving ropivacaine total of 150 mg at TAP under US

Group Type EXPERIMENTAL

Ultrasound guided subcostal TAP block

Intervention Type PROCEDURE

Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.

Interventions

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Ultrasound guided subcostal TAP block

Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.

Intervention Type PROCEDURE

Placebo Ultrasound guided subcostal TAP block

Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I-II
* Age 20-65 patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria

* Patient refusal
* Allergy to ropivacaine
* Coagulopathy
* Morbid obesity (BMI\>35 kg/m2)
* Previous abdominal surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kim Sang-Hyun

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Hyun Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

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Sang-Hyun Kim

Bucheon-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-Hyun Kim, M.D., Ph.D.

Role: CONTACT

Phone: 82-32-621-5328

Email: [email protected]

Facility Contacts

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Sang-Hyun Kim, M.D., Ph.D.

Role: primary

Other Identifiers

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schbcanesthesia

Identifier Type: -

Identifier Source: org_study_id