Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection

August 2, 2012 updated by: Ji Won Park, National Cancer Center, Korea
The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 20~80
  • undergoing laparoscopic colectomy

Exclusion Criteria:

  • allergic history to local anesthesitcs
  • tolerance to opioid
  • cannot use IV-PCA
  • previous abdominal surgery
  • intestinal obstruction
  • emergency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: an odd numbered patients
TAP block with local anesthetics
Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Drug: bupivacaine
0.25 bupivacaine 30ml (15ml on each side)
PLACEBO_COMPARATOR: an even numbered patients
TAP block without local anesthetics
Drug: Placebo
placebo
Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block
Ultrasound Guided Transversus Abdominis Plane (TAP) Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score during cough
Time Frame: 24hr after TAP block
pain score during cough at 24 hours after TAP block (using visual analog scale)
24hr after TAP block

Secondary Outcome Measures

Outcome Measure
Time Frame
pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality
Time Frame: 24hr, 48hr, 72hr after TAP block
24hr, 48hr, 72hr after TAP block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (ESTIMATE)

August 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-11-557

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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