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TAP: The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section

Sponsor
Gia Dinh People Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03634111
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8.7
Actual Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Transversus abdominis plane block under the ultrasound guidanceTransversus abdominis plane block under the ultrasound guidance
Masking:
None (Open Label)
Masking Description:
Participants were cesarean section with general anesthesia
Primary Purpose:
Other
Official Title:
The Transversus Abdominis Plane Block
Actual Study Start Date :
Jul 10, 2017
Actual Primary Completion Date :
Jul 15, 2017
Actual Study Completion Date :
Mar 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: T group

The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.

Procedure: TAP block
TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
Other Names:
  • Transversus abdominis plane block

    • Drug: Morphine
    Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
    Other Names:
  • Opioids

    • Drug: Ropivacaine
    Ropivacaine 0.25% 20 ml each side
    Other Names:
  • Anaropin

    		•
    Placebo Comparator: C group

    The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia

    Drug: Morphine
    Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
    Other Names:
  • Opioids

    • Drug: Ropivacaine
    Ropivacaine 0.25% 20 ml each side
    Other Names:
  • Anaropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total morphine consumption during 24 hours [24 hours]

      Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).

    Secondary Outcome Measures

    1. The time required the first of dose of morphine (hours) [24 hours]

      The time was from the end of surgery to the participants required the first of dose of morphine with PCA.

    2. Pain score: VAS [24 hours]

      Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain

    3. The rate of complications of TAP block [24 hours]

      There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall

    4. The rate of side effect of morphine [24 hours]

      There were rate of sedation, respiratory failure, nause and vomiting, pruritus

    5. The satisfaction of participants: Likert [24 hours]

      It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Cesarean section with general anesthesia.

    • The ASA classification was from II to III

    Exclusion Criteria:

    • The acute fetal impairment.

    • The severe live or renal failure.

    • Tolerance opioids

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 THANG Nguyen Trong Ho Chi Minh Vietnam 700000

    Sponsors and Collaborators

    • Gia Dinh People Hospital

    Investigators

    • Principal Investigator: THANG T Nguyen, Mr, Gia Dinh People Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gia Dinh People Hospital
    ClinicalTrials.gov Identifier:
    NCT03634111
    Other Study ID Numbers:
    • 11-2017/CN-HĐĐĐ
    First Posted:
    Aug 16, 2018
    Last Update Posted:
    Aug 16, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gia Dinh People Hospital
    transversus abdominis plane block (TAP block)
    postoperative analgesia
    cesarean section
    Additional relevant MeSH terms:
    Labor Pain
    Morphine
    Ropivacaine

    Study Results

    No Results Posted as of Aug 16, 2018