Clinical trial NCT03634111: The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section
Official title: The Transversus Abdominis Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Pain
Keywords: transversus abdominis plane block (TAP block)
postoperative analgesia
cesarean section
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Transversus abdominis plane block under the ultrasound guidance
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Total morphine consumption during 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: The time required the first of dose of morphine (hours)
timeFrame: 24 hours
measure: Pain score: VAS
timeFrame: 24 hours
measure: The rate of complications of TAP block
timeFrame: 24 hours
measure: The rate of side effect of morphine
timeFrame: 24 hours
measure: The satisfaction of participants: Likert
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: THANG Nguyen Trong
Study officials:
affiliation: Gia Dinh People Hospital
name: THANG T Nguyen, Mr
role: PRINCIPAL_INVESTIGATOR
References: