Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG)

The Analgesic Efficacy of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Pericapsular Nerve Group Block( PENG) in Patients Undergoing Laparoscopic Shoulder Surgeries: A Randomized Controlled Trial

Patients are greatly concerned about pain that occurs shortly after shoulder surgeries. Most patients experience significant pain after shoulder surgery, with almost half reporting severe pain immediately after. Since shoulder surgeries are usually done as outpatient or one day procedures, good pain control after surgery is important for quick recovery and rehab for patient's overall recovery. Interscalene nerve blocks provide the best pain relief for shoulder surgery patients. They reduce pain for at least 8 hours and decrease the need for opioids for 8 to 12 hours after surgery. It anesthetizes most of the brachial plexus, except the ulnar nerve (C8-T1). It is useful for surgeries on the distal clavicle, shoulder, and proximal humorous .However, interscalene blocks also raise concerns about temporary and potential long-term problems with breathing, especially paralysis of the diaphragm and phrenic nerve. By targeting nerve roots in the neck rather than peripheral nerves, interscalene blocks also carry a higher risk of nerve damage.The pericapsular nerve group block has been effectively used in hip surgeries as in hip arthroplasty and it is one of the best regional anesthesia regarding many other hip operations. Recently PENG block has also shown to have strong analgesic effect on shoulder surgeries.

Dexmedetomidine (DEX) is a highly selective Alpha-2 adrenergic agonist. It has sedative and analgesic properties that thought to be due to binding to both presynaptic and postsynaptic alpha-2 adrenoreceptors and inhibiting the release of norepinephrine, as a result, it terminates the propagation of pain signals and inhibits the sympathetic activity decreasing heart rate and blood pressure.

The aim of our study is to compare the effect of adding dexmedetomidine to bupivacaine in ultrasound-guided Pericapsular nerve group block (PENG) with bupivacaine alone and determine its effect on duration of analgesia and post-operative opioid consumption.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: nerve block

Detailed Description

Patients meeting the inclusion criteria will be randomly assigned to receive either:

Group A: PENG block with bupivacaine only (number of patients: 42) Group B: PENG block with bupivacaine and dexmedetomidine (number of patients: 42)

Preoperative assessment:

Preoperative assessment of all patients undergoing elective laparoscopic shoulder surgical procedures under general anaesthesia comprised of history taking, clinical examination, laboratory testing (complete blood count, kidney function tests, and liver function tests), electrocardiogram, and chest X-ray. The study protocol will be explained to the patients, and their consent will be obtained.

The visual analogue score (VAS) will be explained to all patient in details as it will be used as a measurement tool for assessment of postoperative pain

Operating Room preparation & Equipment:

The ultrasound used will be Siemens ACUSON X300 Ultrasound System, the scanning probe is a linear probe 8-14 MHZ. A 50-mm block needle 22 gauge will be used. (SonoPlex Stim Cannula, Germany).

All blocks will be given by one researcher using 20 ml of drug 0.25% bupivacaine either alone or with dexmedetomedine.

After arrival to the anesthetic room, an 18-gauge intravenous cannula will be placed at the forearm contralateral to the operated arm, standard monitoring will be used (non-invasive arterial blood pressure, ECG, pulse oximetry).

Premedication will be given intravenously in the form of 0.03 mg/kg midazolam, ranitidine 2.0 mg/kg IV and metoclopramide 0.1 mg/kg IV).

Patients will be randomly assigned to either the intervention group will receive PENG block with bupivacaine 0.25% and dexmedetomidine 1 µg/kg (maximum dose of 100 µg) diluted in normal saline (total volume of 20 mL) or control group will receive PENG block with bupivacaine 0.25% (20 mL) diluted in normal saline.

PENG block:

The patient will be asked to lie supine with his or her arm then positioned in a 45-degree abducted external rotation. A linear ultrasound probe was placed lengthwise between the coracoid and humeral head. Once the humeral head, subscapular muscle tendon, and deltoid muscle were identified, a 50-mm needle will be inserted using the "in plane" technique. The needle then will be advanced through the deltoid muscle and towards the subscapularis tendon, until a bony-like hard tissue is felt, preventing further advancement of the needle. The needle is placed now between the deltoid muscle and subscapularis tendon in which injection will be done.

Thirty minutes after performing the block patients will receive general anaesthesia. Anaesthesia will be induced with propofol (2 mg/kg), fentanyl (2 μg/kg) and atracurium (0.5 mg/kg). The GA will be maintained by isoflurane (1.2 %) and Atracurium (0.1 mg/kg/20 min). the surgery will then be started and intraoperative vital signs as heart rate, MAP (mean arterial blood pressure) will be monitored all throughout. If at anytime during the operation hypertension and tachycardia were observed, fentanyl 50 mic will be given as an intraoperative rescue analgesia.

After skin closure, muscle relaxation will be reversed using Neostigmine (0.04mg/kg) and Atropine (0.01mg/kg) after the return of spontaneous breathing. After extubation patients will be transferred to the post-anesthesia care unit (PACU) for 60 min for complete recovery and monitoring.

If at any point hypotension occurred (defined as a decrease in mean arterial pressure > 25% from the baseline value or systolic arterial pressure of 100 mmHg), it will be treated with 5 mg of IV bolus ephedrine, which will be repeated every 3 min until the hypotension resolved. Bradycardia (defined as an HR of 40 beats/min) will be treated with intravenous atropine (0.5 mg).

Postoperative vital signs (heart rate and MAP) and VAS for pain will be recorded at 0, 2, 6, 12, 24 hours and if VAS ≥3 or when the patient asks for analgesia, morphine IV (0.1mg/kg) will be given (rescue analgesia) targeting VAS ≤ 2 while the maximum allowed dose of morphine is 30 mg / 24 hours. The time to first call for analgesia is defined as (the time interval from tracheal extubation to first dose of morphine administration) will be recorded. The patient will receive paracetamol (1gm/8hrs IV) as a regular analgesia as soon as he is discharged from the recovery and admitted to the post-operative ward. The total amount of morphine in the first postoperative 24 hours will be calculated in both groups If the patient requires more than two doses of rescue analgesia in the first hour following surgery, the block will be deemed to have failed.

-Post operative haemodynamic will be assessed (heart rate and MAP at the same time point).

Incidence of adverse effects, such as hypotension, bradycardia, and sedation.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed nabih, lecturer; Phone Number: +201002773488; Email: nabihomar100@yahoo.com
• Study Contact Backup: Name: Mohammed Belita, lecturer; Phone Number: +201001007485; Email: mbeleta75@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alainy
    • Contact: Ahmed nabih, lecturer; Phone Number: +201002773488; Email: nabihomar100@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female patients aged 18-65 years
2. Patients Undergoing laparoscopic shoulder surgeries (shoulder arthroplasties and shoulder endoscopic surgeries )
3. American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

1. Patient refusal.
2. hypersensitivity or contraindication to dexmedetomidine
3. History of allergy or intolerance to study medications
4. Chronic opioid use (>3 months)
5. Pregnancy or breastfeeding
6. Severe renal or hepatic impairment
7. Patient's with coagulopathy disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PENG block with bupivacaine; ultrasound-guided Pericapsular nerve group block with bupivacaine	Procedure: nerve block; ultrasound-guided Pericapsular nerve group block
Experimental: PENG block with bupivacaine and dexmedetomidine; ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine	Procedure: nerve block; ultrasound-guided Pericapsular nerve group block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	it is defined as time from extubation until time to first analgesic requirement during the first 24 hours postoperatively.	the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total opioid consumption	The total opioid consumption in mg	the first 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: Nasr Abdallah, Professor, anesthesia department , cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Joint Diseases; Arthralgia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Pain; Surgical Procedures, Operative; Anesthesia and Analgesia; Neurosurgical Procedures; Anesthesia, Conduction; Anesthesia; Denervation; Nerve Block
• Other Study ID Numbers: MS -493-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No