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

NCT06550180 | Completed

• 1 other identifier: CT2024-001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the time to first request of opioid analgesia.

  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.

  24 hours

Secondary Outcomes (1)

• total dose of intraoperative analgesic needs

  24 hours

Study Arms (2)

Spinal anaesthesia group (S)

EXPERIMENTAL

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

Drug: Spinal anaesthesia group (S)

oblique Subcostal TAP block and spinal anaesthesia group (OSTAP)

EXPERIMENTAL

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.

Drug: Subcostal TAP block and spinal anesthesia group (STAP)

Interventions

Spinal anaesthesia group (S) 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

Spinal anaesthesia group (S)

Subcostal TAP block and spinal anesthesia group (STAP) 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

oblique Subcostal TAP block and spinal anaesthesia group (OSTAP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Egyptian liver hospital

Al Mansurah, Mansoura, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: May 28, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)