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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634111
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gia Dinh People Hospital

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
Obstetric Pain Procedure: TAP block Drug: Morphine Drug: Ropivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Transversus 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 : July 10, 2017
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Opioids

Drug: Ropivacaine
Ropivacaine 0.25% 20 ml each side
Other Name: 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 Name: Opioids

Drug: Ropivacaine
Ropivacaine 0.25% 20 ml each side
Other Name: Anaropin




Primary Outcome Measures :
  1. Total morphine consumption during 24 hours [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 hours ]
    There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall

  4. The rate of side effect of morphine [ Time Frame: 24 hours ]
    There were rate of sedation, respiratory failure, nause and vomiting, pruritus

  5. The satisfaction of participants: Likert [ Time Frame: 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



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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634111


Locations
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Vietnam
THANG Nguyen Trong
Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
Gia Dinh People Hospital
Investigators
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Principal Investigator: THANG T Nguyen, Mr Gia Dinh People Hospital
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Responsible Party: Gia Dinh People Hospital
ClinicalTrials.gov Identifier: NCT03634111    
Other Study ID Numbers: 11-2017/CN-HĐĐĐ
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Labor Pain
Pain
Neurologic Manifestations
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics