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Clinical Trials/NCT03634111
NCT03634111
Completed
Not Applicable

The Transversus Abdominis Plane Block

Gia Dinh People Hospital1 site in 1 country60 target enrollmentJuly 10, 2017

Overview

Phase
Not Applicable
Intervention
TAP block
Conditions
Obstetric Pain
Sponsor
Gia Dinh People Hospital
Enrollment
60
Locations
1
Primary Endpoint
Total morphine consumption during 24 hours
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2017
End Date
March 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gia Dinh People Hospital
Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

T group

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

Intervention: TAP block

T group

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

Intervention: Morphine

T group

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

Intervention: Ropivacaine

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

Intervention: Morphine

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

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 Outcomes

  • The time required the first of dose of morphine (hours)(24 hours)
  • Pain score: VAS(24 hours)
  • The rate of complications of TAP block(24 hours)
  • The rate of side effect of morphine(24 hours)
  • The satisfaction of participants: Likert(24 hours)

Study Sites (1)

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