Combined Ultrasound Guided Bilateral Rectus Sheath and Erector Spinae Plain Blocks Versus Erector Spinae Plain Block for Intra and Postoperative Analgesia in Elective Abdominoplastic Surgeries. a Randomized Controlled Double Blinded Trial.

NCT06765772 | Recruiting

• 1 other identifier: MS-370-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trail is to determine if bilateral erector spinae plane block alone can provide good perioperative analgesia for abdominoplastic surgery patients or it is better to give combined bilateral rectus sheath and erector spinae plane blocks to achieve effective intraoperative and postoperative analgesia with minimal morphine consumption in such operations in which there is an extensive surgical dissection and a high risk of respiratory problems.

Conditions

Abdominoplasty; Perioperative Analgesia

Keywords

Rectus sheath block; Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Visual Analogue Scale (VAS) measures pain intenesity one hour after extubation

  one hour

Secondary Outcomes (2)

• Secondary Outcome

  first 24 hours postoperative

• Secondary Outcome

  During opration

Study Arms (2)

Group A

ACTIVE COMPARATOR

20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia

Procedure: Erector spinae plane block; Procedure: Rectus sheath block

Group B

ACTIVE COMPARATOR

20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

the patient will recieve ultrasound guided erector spinae plane blockbe. A 20-gauge needle will be placed between the erector spinae muscle and the thoracic transverse processes at the level of T10 using an 'in plane' technique, 20 ml of (0.25% bupivacaine and 1% xylocaine) will be injected on each side.

Group A; Group B

Rectus sheath block PROCEDURE

the patient will recieve ultrasound guided rectus sheath block. An 18-gauge needle will be introduced- in plane- just below the costal margin at an angle of approximately 45 degrees to the skin between the rectus abdominis muscle and posterior rectus sheath. 10 ml of (0.25% bupivacaine and 1% xylocaine) will be injected on each side.

Group A

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients Age from 21 to 60 years ,Male and female patients ,ASA I, II patients scheduled for elective abdominoplastic surgeries during the study duration.

You may not qualify if:

• Patient refusal, Age less than 21 and above 60 years old, ASA III, IV patients., Infection at the site of injection, Opioid addiction, Allergy to any used substances (lidocaine, bupivacaine)., Preexisting severe or uncontrolled respiratory, renal or cardiac disease. , INR more than 1.5 and platelets less than 100000.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospital

Cairo, Cairo Governorate, 4240310, Egypt

RECRUITING

Study Officials

• Hassan Mohamed Ali, Phd

  Professor of anesthesia Cairo university faculty of medicine

  STUDY DIRECTOR

Central Study Contacts

yahya Mohamed Hammad, MD

CONTACT

00201114048081; yahya196cm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Model Details: 2 groups A\&B In Group A: GA along with combined Rectus sheath and Erector spinae plane blocks. In Group B: General anesthesia along with Erector spinae plane block alone.

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 9, 2025
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-12

Locations

EG (1)