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

NCT ID: NCT06235879

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-01

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.

Detailed Description

Shoulder arthroscopy can effectively treat a number of injuries and diseases of the shoulder on an ambulatory basis. Although shoulder arthroscopy is considered minimally invasive, it is related to severe postoperative pain. The use of arthroscopy is popular because it decreases pain, shortens hospital stay, and improves patient satisfaction. However, immediate postoperative pain remains to be a problem in more than 40% of patients.

Regional anesthesia, especially peripheral nerve blocks have various advantages like decreased need for postoperative analgesics, decreased incidence of nausea and vomiting, shortened recovery time and hospital stay, Early ambulation and discharge.

Interscalene brachial plexus (ISB) block is considered the gold standard technique for pain management in shoulder surgery as it provides the most reliable analgesia. However, it has the potential for many complications. The most common of these complications is phrenic nerve palsy, which is reversible but may result in significant respiratory distress especially in patients with compromised respiratory function. Other less common yet serious complications include Horner's syndrome, recurrent laryngeal nerve block that may result in hoarseness of voice, vascular puncture, brachial plexus neuropathy, and unintended injection of local anesthetic into the subarachnoid space, epidural space, or vertebral artery.

Pericapsular nerve group (PENG) block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia by reaching the sensory nerve branches of the glenohumeral joint.

Conditions

Pericapsular Nerve Block; Interscalene Brachial Plexus Block; Shoulder Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (Control Group

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

Group Type: OTHER

Control Group (Interscalene brachial plexus block)

Intervention Type: 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 B (Pericapsular nerve group (PENG) block)

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

Group Type: EXPERIMENTAL

Pericapsular nerve group (PENG) block

Intervention Type: 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.

Interventions

Control Group (Interscalene brachial plexus block)

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).

Intervention Type: OTHER

Pericapsular nerve group (PENG) block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sabry B Mohamed

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammed S Mohammed, Master

Role: CONTACT

mohamedsabry0101808@med.asu.edu.eg

00201060103441

Facility Contacts

Mohammed S Mohammed, Master

Role: primary

mohamedsabry0101808@med.asu.edu.eg

00201060103441

Other Identifiers

FMASU MD298/2023

Identifier Type: -

Identifier Source: org_study_id