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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01418391
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversus Abdominis Plane block
 N/A

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 06 h, 612 h, 1224 h, 2436 h, and 36~48 h ,respectively. The total amount of morphine consumption was also counted.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Study Start Date :
Jun 1, 2011
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. amount of post-operative morphine consumption [post-operative 48 hours]

    Secondary Outcome Measures

    1. evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale [post-operative 48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 department of anesthesia, Kaohsiung medical university memorial hospital Kaohsiung Taiwan 807

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01418391
    Other Study ID Numbers:
    • KMUH-IRB-990400
    • KMUH-IRB-990400
    First Posted:
    Aug 17, 2011
    Last Update Posted:
    Aug 17, 2011
    Last Verified:
    May 1, 2011
    Keywords provided by , ,
    minimal laparotomy
    TAP block
    morphine consumption
    post-operative analgesia
    Additional relevant MeSH terms:
    Colonic Neoplasms

    Study Results

    No Results Posted as of Aug 17, 2011