Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Study Overview
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Brief Summary
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The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Detailed Description
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Caesarean delivery rates have been increasing worldwide nowadays. At rate of [52%], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries. A much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section.

Official Title
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Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial

Conditions
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Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block, Bupivacaine, Acute Pain

Intervention / Treatment
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* Procedure: surgical TAP block
* Procedure: US guided TAP block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term pregnant women Older than 21 years of age Had elective cesarean section with Pfannenstiel incision. Exclusion Criteria: Patients with cesarean section using different surgical incision History of addiction [including opioids and benzodiazepines] Allergy to the anesthetic analgesia Psychological disorders Coagulopathies Infection at the block injection site.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical TAP block<br>twenty-five pregnant women will receive surgical TAP block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon. | Procedure: surgical TAP block<br>* performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.<br>* Other names: bupivacaine, normal saline, fentanyl, pethidine;|
| Active Comparator: US guided TAP block<br>25 pregnant women will receive US guided T.A.P block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally. | Procedure: US guided TAP block<br>* performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.<br>* Other names: bupivacaine, normal saline, fentanyl , pethidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perform block. | The time taken to perform the block will be recorded by an independent observer. | 1 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Patients hemodynamics (heart rate will be recorded) | 24 hours postoperatively | 
| Mean arterial blood pressure | Patients hemodynamics (mean arterial blood pressure will be recorded) | 24 hours postoperatively | 
| Pain score | The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | 24 hours postoperatively | 
| Time to first analgesic request | The time to first analgesic request will be recorded | 24 hours postoperatively | 
| Amount of post operative analgesic consumption | The amount of post operative analgesic consumption will be recorded | 24 hours postoperatively | 
| Time spent in operating room | The time spent in operating room will be recorded | 24 hours postoperatively | 
| Incidence of Adverse reactions | Adverse events will be recorded such as nausea, vomiting, hypotension (Mean arterial blood pressure < 20% of baseline readings and will be managed by ephedrine 5 mg IV and/or normal saline IV) and bradycardia (heart rate < 60 beats/min and will be managed by atropine 0.6 mg IV). | 24 hours postoperatively |