Comparison Between Pericapsular Nerve Group (PENG) Block and Interscalene Brachial Plexus Block for Postoperative Analgesia Following Shoulder Arthroscopy

NCT06235879 | Recruiting

• 1 other identifier: FMASU MD298/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to compare ultrasound guided pericapsular nerve group (PENG) block versus interscalene brachial plexus block for postoperative analgesia following shoulder arthroscopy.

Conditions

Pericapsular Nerve Block; Interscalene Brachial Plexus Block; Shoulder Arthroscopy

Outcome Measures

Primary Outcomes (1)

• First time for requiring analgesia

  First time for requiring analgesia. It will be defined as the time from recovery until VAS score greater than 3.

  24 hours postoperatively

Secondary Outcomes (3)

• Total amount of pethidine consumption in the first 24 hours

  24 hours postoperatively

• The degree of pain

  24 hours postoperatively

• Complications

  24 hours postoperatively

Study Arms (2)

Group A (Control Group

OTHER

Patients will receive ultrasound guided Interscalene brachial plexus (ISB) block after induction of general anesthesia.

Other: Control Group (Interscalene brachial plexus block)

Group B (Pericapsular nerve group (PENG) block)

EXPERIMENTAL

Patients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia

Procedure: Pericapsular nerve group (PENG) block

Interventions

Control Group (Interscalene brachial plexus block) OTHER

Patients will receive ultrasound guided interscalene brachial plexus block after induction of general anesthesia. Scanning with SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) will be started just below the level of the cricoid cartilage medial to the sternocleidomastoid muscle. the transducer will be moved slightly laterally across the neck to identify the scalene muscles and the brachial plexus that is present between the anterior and middle scalene muscles at the level of the sixth cervical vertebra deep to the sternocleidomastoid muscle. The needle will be then inserted in-plane toward the brachial plexus, in a lateral-to-medial direction. After negative aspiration and assurance that high resistance to injection is absent, 0.25% bupivacaine hydrochloride will be injected in a 5-ml increment below the lower root, between the 3 roots, and above the upper root.(Total amount is 15 ml of 0.25% bupivacaine hydrochloride).

Group A (Control Group

Pericapsular nerve group (PENG) block PROCEDURE

Patients will receive ultrasound guided Pericapsular nerve group (PENG) block after induction of general anesthesia. Using SonoSite M-Turbo C ® Ultrasound device with HFL - 38 X Linear probe (Japan) with high frequency (6 -13 MHz) ,A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle can't be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, after a careful aspiration, 15 ml of 0.25% bupivacaine hydrochloride will be injected.

Group B (Pericapsular nerve group (PENG) block)

Eligibility Criteria

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

You may qualify if:

• \- Age from 18 to 60 years old. - Both genders. - BMI ≤35 kg/m2. - American Society of Anesthesiologists Physical Status (ASA-PS) Class I and II. - Patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery.

You may not qualify if:

• Refusal of procedure or participation in the study
• Patient under age of 18 years old or above 60 years' old
• Physical status: ASA-PS III or above.
• Pregnancy or lactation.
• Infection at site of injection.
• Psychiatric illness.
• CNS Diseases like (epilepsy, stroke …etc.) or neurological disease affecting patient's upper limb.
• Evidence of coagulopathy or anticoagulation.
• Patients with respiratory disease, renal or hepatic insufficiency.
• infection of the skin in the puncture area.
• Allergy against any of the drugs to be used.
• Obesity (BMI \>35 kg/m2).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Interventions

Control Groups; Dental Occlusion

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Mohammed S Mohammed, Master

CONTACT

00201060103441; mohamedsabry0101808@med.asu.edu.eg

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: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

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)