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

NCT07626346 | Recruiting

• 1 other identifier: MS -493-2023
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The total opioid consumption

  the first 24 hours postoperatively

Study Arms (2)

PENG block with bupivacaine

EXPERIMENTAL

ultrasound-guided Pericapsular nerve group block with bupivacaine

Procedure: nerve block

PENG block with bupivacaine and dexmedetomidine

EXPERIMENTAL

ultrasound-guided Pericapsular nerve group block with bupivacaine and dexmedetomidine

Procedure: nerve block

Interventions

nerve block PROCEDURE

ultrasound-guided Pericapsular nerve group block

PENG block with bupivacaine; PENG block with bupivacaine and dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Nasr Abdallah, Professor

  anesthesia department , cairo university

  STUDY DIRECTOR

Central Study Contacts

Ahmed nabih, lecturer

CONTACT

+201002773488; nabihomar100@yahoo.com

Mohammed Belita, lecturer

CONTACT

+201001007485; mbeleta75@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anethesia

Model Details: Patients will be randomly allocated by a computer-generated table into two of the study groups, the randomization sequence had been concealed in sealed opaque envelopes that will be opened by third doctor who will not participating in the study. The details of the series will be unknown to the investigators and the group assignment will kept in a set of sealed envelopes each bearing only the case number on the outside. This study will be performed by 2 anesthetists; one anesthetist who is experienced in performing the blocks that allocated to perform PENG block with either bupivacaine alone (control group) or bupivacaine with dexmedetomidine (intervention group). According to a computer-generated sequence of random numbers and sealed envelope, and the other anesthetist will be blinded to the technique performed, and will monitor the patients intra and postoperatively.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

EG (1)