the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial

August 16, 2011 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It had been reported the effect of post-operative pain control in minor abdominal surgery, such as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

outcome measures:

  • Hemodynamic parameters (mean artery pressure, heart rate): recorded at time points of before induction of general anesthesia (baseline), after tracheal intubation immediately, after surgery started 1, 2, 3, 4, 5, 10, 15, 20, 25, and 30 min; then recorded them every 10 mins.
  • Post-operative morphine consumption: recorded morphine consumption at the time intervals of post-operative 0~6 h, 6~12 h, 12~24 h, 24~36 h, and 36~48 h ,respectively. The total amount of morphine consumption was also counted.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • department of anesthesia, Kaohsiung medical university memorial hospital
        • Contact:
        • Principal Investigator:
          • Hung-Te Hsu, VS

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger

Exclusion Criteria:

  • increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
  • a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: morphine consumption
Procedure: Transversus Abdominis Plane block

TAP BLOCK:

dosage form: 0.5% bupivacaine 75mg with 2% xylocaine 300 mg mixed dosage: total 30 ml frequency: single shot duration: 12~18 hours upon to the regional anesthetics choose

Other Names:
  • TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of post-operative morphine consumption
Time Frame: post-operative 48 hours
post-operative 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale
Time Frame: post-operative 48 hours
post-operative 48 hours

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Principal Investigator: Hung-Te Hsu, VS, Department of anesthesia, Kaoshiung medical university hospital

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

June 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-990400 (Other Identifier: KaohsiungMU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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