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Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

Not Applicable
Recruiting
Conditions
Surgical Transversus Abdominis Plane Block
Cesarean Section
Acute Pain
Ultrasound Guided Transversus Abdominis Plane Block
Bupivacaine
Interventions
Procedure: surgical TAP block
Procedure: US guided TAP block
Registration Number
NCT05750992
Lead Sponsor
Al-Azhar University
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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
surgical TAP blocksurgical TAP blocktwenty-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.
US guided TAP blockUS guided TAP block25 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.
Primary Outcome Measures
NameTimeMethod
Time to perform block.1 hour postoperatively

The time taken to perform the block will be recorded by an independent observer.

Secondary Outcome Measures
NameTimeMethod
Mean arterial blood pressure24 hours postoperatively

Patients hemodynamics (mean arterial blood pressure will be recorded)

Heart rate24 hours postoperatively

Patients hemodynamics (heart rate will be recorded)

Amount of post operative analgesic consumption24 hours postoperatively

The amount of post operative analgesic consumption will be recorded

Incidence of Adverse reactions24 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).

Pain score24 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 request24 hours postoperatively

The time to first analgesic request will be recorded

Time spent in operating room24 hours postoperatively

The time spent in operating room will be recorded

Trial Locations

Locations (1)

Kohaf

🇪🇬

Cairo, Egypt

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