Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: surgical TAP block 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
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.
Other Names:
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| Active Comparator: US guided TAP block 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to perform block. [1 hour postoperatively]
The time taken to perform the block will be recorded by an independent observer.
Secondary Outcome Measures
- Heart rate [24 hours postoperatively]
Patients hemodynamics (heart rate will be recorded)
- Mean arterial blood pressure [24 hours postoperatively]
Patients hemodynamics (mean arterial blood pressure will be recorded)
- Pain score [24 hours postoperatively]
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').
- Time to first analgesic request [24 hours postoperatively]
The time to first analgesic request will be recorded
- Amount of post operative analgesic consumption [24 hours postoperatively]
The amount of post operative analgesic consumption will be recorded
- Time spent in operating room [24 hours postoperatively]
The time spent in operating room will be recorded
- Incidence of Adverse reactions [24 hours postoperatively]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Full term pregnant women
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Older than 21 years of age
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Had elective cesarean section with Pfannenstiel incision.
Exclusion Criteria:
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Patients with cesarean section using different surgical incision
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History of addiction [including opioids and benzodiazepines]
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Allergy to the anesthetic analgesia
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Psychological disorders
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Coagulopathies
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Infection at the block injection site.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kohaf | Cairo | Egypt | 11865 |
Sponsors and Collaborators
- Al-Azhar University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DFM-IRB 00012367- 23-02-006