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

NCT ID: NCT06550180

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-04-01

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.

Conditions

Abdominoplasty; Spinal Anaesthesia; Transversus Abdominis Plane Block (TAP Block)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Spinal anaesthesia group (S)

patient in S group They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl.

Group Type: EXPERIMENTAL

Spinal anaesthesia group (S)

Intervention Type: DRUG

Spinal anaesthesia is given to all patients 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)

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.

Group Type: EXPERIMENTAL

Subcostal TAP block and spinal anesthesia group (STAP)

Intervention Type: DRUG

patient receive Subcostal TAP block before spinal anesthesia. Patients in STAP group will receive 20 ml of 0.25% isobaric bupivacaine for each side before spinal anesthesia

Interventions

Spinal anaesthesia group (S)

Spinal anaesthesia is given to all patients in S group. They will receive 20 mg of 0.5% hyperbaric bupivacaine plus 25 microgram fentanyl

Intervention Type: DRUG

Subcostal TAP block and spinal anesthesia group (STAP)

patient receive Subcostal TAP block before spinal anesthesia. Patients in STAP group will receive 20 ml of 0.25% isobaric bupivacaine for each side before spinal anesthesia

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Adel Ali Hassan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Egyptian liver hospital

Al Mansurah, Mansoura, Egypt

Countries

Egypt

Other Identifiers

CT2024-001

Identifier Type: -

Identifier Source: org_study_id