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RecruitingNCT06235879Updated Feb 2, 2024

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

An interventional study of Control Group (Interscalene brachial plexus block) and Pericapsular nerve group (PENG) block in Pericapsular Nerve Block, Interscalene Brachial Plexus Block and Shoulder Arthroscopy, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pericapsular Nerve Block
  • Interscalene Brachial Plexus Block
  • Shoulder Arthroscopy
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Group A (Control Group

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

    Other: Control Group (Interscalene brachial plexus block)

  • Experimental
    Group B (Pericapsular nerve group (PENG) block)

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

    Procedure: Pericapsular nerve group (PENG) block

Interventions

  • OtherControl 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).

  • ProcedurePericapsular 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.

06

What researchers measure

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.

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Total amount of pethidine consumption in the first 24 hours

    If the patient complained of pain, intravenous pethidine sulfate will be (50mg/dose) to be repeated on demand (VAS is \> 3) provided that the total 24-hour dosage not to exceed 50 mg every 6 hours.

    Time frame: 24 hours postoperatively

  2. The degree of pain

    The degree of pain will be measured using visual analogue scale (VAS)ranging from 0 to 10, where 0 no pain and 10 maximum pain. It will be evaluated on arrival to PACU (T0) then at 2, 4, 6, 12, and 24 h postoperatively.

    Time frame: 24 hours postoperatively

  3. Complications

    Any complications during and after the performance of the block - for example, pneumothorax, Horner's syndrome, hoarseness of voice, difficulty in breathing, weakness, and paresthesia in the arm will be recorded.

    Time frame: 24 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • Ain Shams University
    Cairo, 11591, Egypt
    • Mohammed S Mohammed, Master · Contact · mohamedsabry0101808@med.asu.edu.eg · 00201060103441
    • Hoda O Mahmoud, Professor · Sub investigator
    • Amin M Al-ansary, Ass-prof · Sub investigator
    • George M Khalil, Ass-prof · Sub investigator
    • Ramy M Hassan, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06235879
Lead sponsor
Ain Shams University
Responsible party
Mohamed Sabry B Mohamed (Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt, Ain Shams University) — Principal investigator
First posted
Feb 1, 2024
Start date
Feb 1, 2024
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Feb 2, 2024

Study contacts

Mohammed S Mohammed, Master
Contact
mohamedsabry0101808@med.asu.edu.eg
00201060103441

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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