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NCT Number: NCT06765772

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.

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.

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Key information

Conditions

Abdominoplasty Perioperative Analgesia

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university hospital

Cairo, Cairo Governorate, 4240310, Egypt

Location status: Recruiting

Location contact

AHMED ABDALWAHAB, MD

CONTACT

[email protected]

00201221467688

About this study

This study is randomized controlled trail in which 40 adult patients (male or female) scheduled for elective abdominoplastic surgeries during the study duration will be randomized into to equal groups to investigate the efficacy of erector spinae plane block alone versus the efficacy of combine use of erector spinae and rectus sheath plane block for intra and postoperative analgesia in abdominoplastic surgery patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary outcome

    Time frame: one hour

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

Secondary outcomes

  1. Secondary Outcome

    Time frame: first 24 hours postoperative

    Total morphine consumption during 1st 24 hours postoperatively

  2. Secondary Outcome

    Time frame: During opration

    Total intraoperative fentanyl consumption.

Study contacts

Contact information is provided by the study sponsor or research team.

yahya Mohamed Hammad, MD

CONTACT

[email protected]

00201114048081

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 9, 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.

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