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

The Transversus Abdominis Plane Block

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Pain
• Intervention / Treatment: Procedure: TAP block; Drug: Morphine; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam, 700000
    • THANG Nguyen Trong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: T group; The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.	Procedure: TAP block; TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.; Other Names: Transversus abdominis plane block; Drug: Morphine; Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.; Other Names: Opioids; Drug: Ropivacaine; Ropivacaine 0.25% 20 ml each side; Other Names: Anaropin
Placebo Comparator: 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	Drug: Morphine; Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.; Other Names: Opioids; Drug: Ropivacaine; Ropivacaine 0.25% 20 ml each side; Other Names: Anaropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption during 24 hours	Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time required the first of dose of morphine (hours)	The time was from the end of surgery to the participants required the first of dose of morphine with PCA.	24 hours
Pain score: VAS	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	24 hours
The rate of complications of TAP block	There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall	24 hours
The rate of side effect of morphine	There were rate of sedation, respiratory failure, nause and vomiting, pruritus	24 hours
The satisfaction of participants: Likert	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	24 hours

Collaborators and Investigators

• Sponsor: Gia Dinh People Hospital
• Investigators: Principal Investigator: THANG T Nguyen, Mr, Gia Dinh People Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: August 12, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: cesarean section; postoperative analgesia; transversus abdominis plane block (TAP block)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ropivacaine; Morphine
• Other Study ID Numbers: 11-2017/CN-HĐĐĐ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No