Clinical trial NCT06550180: The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia
Official title: The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominoplasty
Spinal Anaesthesia
Transversus Abdominis Plane Block (TAP Block)
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome is the time to first request of opioid analgesia.
timeFrame: 24 hours
Secondary outcomes:
measure: total dose of intraoperative analgesic needs
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Egyptian liver hospital
Study officials:
References: