Clinical Trials Directory

Trials / Completed

CompletedNCT03634111

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

The Transversus Abdominis Plane Block

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Gia Dinh People Hospital · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETAP blockTAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
DRUGMorphineSingle dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
DRUGRopivacaineRopivacaine 0.25% 20 ml each side

Timeline

Start date
2017-07-10
Primary completion
2017-07-15
Completion
2018-03-31
First posted
2018-08-16
Last updated
2018-08-16

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT03634111. Inclusion in this directory is not an endorsement.