Clinical trial NCT05136118: Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section
Official title: Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: post-operative analgesia
Transversus Abdominis Plane Block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 308
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures.

Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.

Detailed description: Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and ∏
* primigravidas
* aged 21-40 years
* BMI ˂ 40
* body weight ˃ 60 kg
* singleton pregnancy
* gestational age of ≥37 weeks
* undergoing elective caesarean section under spinal anesthesia.

Exclusion Criteria:

* Parturient refusal
* parturient with a BMI \> 40
* body weight \< 60 kg
* ASA physical status ≥ III
* known local anesthetic (LA) allergy •contraindications to spinal anesthesia
* parturients who received analgesics in the past 24 hours
* infection at the site of the block.

Primary outcomes:
measure: Time to rescue analgesia
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia
timeFrame: 6 months
measure: Number of parturients requiring postoperative analgesia
timeFrame: 6 months
measure: Total dose of pethidine given
timeFrame: 6 months
measure: Time to the parturient's first ambulation
timeFrame: 6 months
measure: The analgesic satisfaction 24 hours after operation
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References: