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

NCT ID: NCT03634111

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-10
• Study Completion Date: 2018-03-31

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.

Conditions

Obstetric Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

T group

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

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: PROCEDURE

TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.

Morphine

Intervention Type: DRUG

Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.

Ropivacaine

Intervention Type: DRUG

Ropivacaine 0.25% 20 ml each side

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

Group Type: PLACEBO_COMPARATOR

Morphine

Intervention Type: DRUG

Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.

Ropivacaine

Intervention Type: DRUG

Ropivacaine 0.25% 20 ml each side

Interventions

TAP block

TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.

Intervention Type: PROCEDURE

Morphine

Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.

Intervention Type: DRUG

Ropivacaine

Ropivacaine 0.25% 20 ml each side

Intervention Type: DRUG

Other Intervention Names

Transversus abdominis plane block; Opioids; Anaropin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Gia Dinh People Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

THANG T Nguyen, Mr

Role: PRINCIPAL_INVESTIGATOR

Gia Dinh People Hospital

Locations

THANG Nguyen Trong

Ho Chi Minh City, , Vietnam

Countries

Vietnam

Other Identifiers

11-2017/CN-HĐĐĐ

Identifier Type: -

Identifier Source: org_study_id