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.

NCT ID: NCT06765772

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominoplasty Perioperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A

20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type 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

Intervention Type 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 B

20 Adult patients scheduled for elective abdominoplastic surgeries under general anethesia

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type 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.

Interventions

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Erector spinae plane block

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.

Intervention Type PROCEDURE

Rectus sheath block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hassan Mohamed Ali

Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hassan Mohamed Ali, Phd

Role: STUDY_DIRECTOR

Professor of anesthesia Cairo university faculty of medicine

Locations

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Cairo university hospital

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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yahya Mohamed Hammad, MD

Role: CONTACT

00201114048081

Facility Contacts

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AHMED ABDALWAHAB, MD

Role: primary

00201221467688

Other Identifiers

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MS-370-2024

Identifier Type: -

Identifier Source: org_study_id

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