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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Transversus Abdominis Plane Block

Conditions
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Obstetric Pain

Intervention / Treatment
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* Procedure: TAP block
* Drug: Morphine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Transversus abdominis plane block under the ultrasound guidance
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversus abdominis plane block (TAP block), postoperative analgesia, cesarean section