Skip to main content
OpenTrials
Completed

NCT Number: NCT06550180

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egyptian liver hospital

Al Mansurah, Mansoura, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. total dose of intraoperative analgesic needs

    Time frame: 24 hours

    opioid dose by microgram

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.