Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgical TAP block, US guided TAP block.
- Who it may be relevant to
- Registry conditions: Cesarean Section, Ultrasound Guided Transversus Abdominis Plane Block, Surgical Transversus Abdominis Plane Block, Bupivacaine. Basic parameters: 21 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial
Overview
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
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.
Interventions
- 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. - 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.
Primary outcome measures
- Time to perform block. [Time frame: 1 hour postoperatively]
Secondary outcome measures (7)
- Heart rate [Time frame: 24 hours postoperatively]
- Mean arterial blood pressure [Time frame: 24 hours postoperatively]
- Pain score [Time frame: 24 hours postoperatively]
- Time to first analgesic request [Time frame: 24 hours postoperatively]
- Amount of post operative analgesic consumption [Time frame: 24 hours postoperatively]
- Time spent in operating room [Time frame: 24 hours postoperatively]
- Incidence of Adverse reactions [Time frame: 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kohaf — Cairo
Identifiers
NCT: NCT05750992 · DFM-IRB 00012367- 23-02-006