The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia

Not Applicable

Completed

• Conditions: Abdominoplasty; Spinal Anaesthesia; Transversus Abdominis Plane Block (TAP Block)
• Interventions: Drug: Spinal anaesthesia group (S); Drug: Subcostal TAP block and spinal anesthesia group (STAP)

• Registration Number: NCT06550180
• Lead Sponsor: Helwan University

Brief Summary

The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of postoperative side effects (nausea, vomiting, hypotension, bradycardia, and pruritic).

Detailed Description

Abdominoplasty is designed to remove fat, skin laxity, and excess skin with the abdominal skin flap. It is a moderately invasive extraperitoneal procedure with or without liposuction. Ambulatory office-based abdominoplasty procedures have recently increased owing to lower cost and global availability of plastic surgeons in addition to better and safer anaesthetic techniques Spinal anaesthesia has many advantages such as pre-emptive analgesia, better control of pain, suppression of the surgical stress response, preservation of perioperative immune function, preservation of oxygenation and pulmonary functional residual capacity and improved visceral vascular flow in addition to reduction in the incidence of venous thrombotic disease and hence pulmonary embolism, as it facilitates early ambulation The addition of adjuvant drugs to local anesthetics and augmenting spinal anesthesia with peripheral nerve blocks would provide time for prolonged surgeries, and it is the ideal technique for procedures below T3-T4. The investigators assume that performing a transversus abdominis plane block (TAP block) just before spinal anesthesia in abdominoplasty would prolong the duration of postoperative analgesia and lessen the number of cases needing sedation or conversion to general anesthesia when compared to spinal anesthesia alone.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-28
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-12
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• American Society of Anaesthesiologists physical status grade I and grade II.
• Age > 18 years and less than 65 years.
• Both sexes.

Exclusion Criteria

• Patient refusal.

  -. Bleeding or coagulation abnormality.

• Local skin infection and sepsis at site of the block.

• Known hypersensitivity to the study drugs.

• Body Mass Index > 50 Kg/m2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anaesthesia group (S)	Spinal anaesthesia group (S)	patient in S group They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl.
oblique Subcostal TAP block and spinal anaesthesia group (OSTAP)	Subcostal TAP block and spinal anesthesia group (STAP)	Patients in (OSTAP) groups had spinal anesthesia administered with 20 mg of 0.5% hyperbaric bupivacaine and 25 mcg of fentanyl. Immediately after giving spinal anesthesia, individuals in the OSTAP group received 35 ml of 0.25% isobaric bupivacaine on each side.

Primary Outcome Measures

Name	Time	Method
The primary outcome is the time to first request of opioid analgesia.	24 hours	assessment of pain by visual analogue scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.

Secondary Outcome Measures

Name	Time	Method
total dose of intraoperative analgesic needs	24 hours	opioid dose by microgram

Trial Locations

Locations (1)

Egyptian liver hospital; 🇪🇬 Mansoura, Egypt