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

Not Applicable
Completed
Conditions
Obstetric Pain
Interventions
Registration Number
NCT03634111
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
T groupTAP blockThe TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.
C groupMorphineThe controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia
T groupMorphineThe TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.
T groupRopivacaineThe TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.
C groupRopivacaineThe controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia
Primary Outcome Measures
NameTimeMethod
Total morphine consumption during 24 hours24 hours

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

Secondary Outcome Measures
NameTimeMethod
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.

Pain score: VAS24 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

The rate of complications of TAP block24 hours

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

The rate of side effect of morphine24 hours

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

The satisfaction of participants: Likert24 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

Trial Locations

Locations (1)

THANG Nguyen Trong

🇻🇳

Ho Chi Minh, Vietnam

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