Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607860511601 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of a Novel “PENG-like” Nerve Block Technique for Pain Management After Shoulder Arthroscopy
Official scientific title PENG-like Block for Shoulder Arthroscopy: Evaluation of an Alternative Analgesic Strategy
Brief summary describing the background and objectives of the trial Postoperative pain following shoulder arthroscopy, particularly rotator cuff repair, is often moderate to severe and may delay early rehabilitation while increase opioid consumption. The interscalene block remains the standard regional analgesic technique; however, it is frequently associated with phrenic nerve palsy and diaphragmatic dysfunction. The PENG-like (Pericapsular Nerve Group-like) block is a novel diaphragm-sparing regional anesthesia technique designed to target the sensory innervation of the anterior glenohumeral capsule while minimizing motor blockade. Preliminary evidence suggests that this approach may provide effective postoperative analgesia with fewer respiratory side effects. This prospective randomized triple-blind controlled study aims to evaluate the analgesic efficacy and safety of the PENG-like block in patients undergoing arthroscopic rotator cuff repair. The primary objective is to compare postoperative pain scores at rest between patients receiving an active PENG-like block and those receiving placebo. Secondary objectives include assessment of perioperative opioid consumption, time to first analgesic request, preservation of motor function, incidence of postoperative adverse events, patient satisfaction, and postoperative complications. The study protocol remains unchanged. This update is submitted following the reviewers' request for resubmission.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PENG-like SHOULDER Trial
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2026
Actual trial start date
Anticipated date of last follow up 01/11/2026
Actual Last follow-up date 31/12/2026
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Not yet recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PENGlike 20 mL of 0.5% isobaric bupivacaine solution Single perioperative injection (after anesthesia induction) Patients in the intervention group receive an ultrasound-guided PENG-like block performed after anesthesia induction. The block is performed in the supine position using a high-frequency linear ultrasound probe placed between the coracoid process and the humeral head. After identification of anatomical landmarks, a 20-gauge, 50-mm needle is advanced in-plane in a cranio-caudal direction. Following negative aspiration and hydrodissection to confirm correct needle placement, 20 mL of 0.5% isobaric bupivacaine is injected. 20
Control Group Placebo 20 ml of 0.9% sodium chloride (normal saline) Single perioperative injection (after anesthesia induction) Patients in the intervention group receive an ultrasound-guided PENG-like block performed after anesthesia induction. The block is performed in the supine position using a high-frequency linear ultrasound probe placed between the coracoid process and the humeral head. After identification of anatomical landmarks, a 20-gauge, 50-mm needle is advanced in-plane in a cranio-caudal direction. Following negative aspiration and hydrodissection to confirm correct needle placement, 20 mL of 0.9% sodium chloride is injected. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ≥ 18 years ASA physical status I, II, or III Elective arthroscopic rotator cuff repair surgery Signed informed consent Patient refusal Cognitive impairment preventing pain assessment Coagulation disorders (hemostasis disorders) Neurological or muscular disease Known allergy to NSAIDs or paracetamol Known allergy to local anesthetics Block failure Suspected local anesthetic toxicity Occurrence of a severe complication related to anesthesia or surgery Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/05/2026 Institutional Ethics Committee of the Ben Arous Trauma and Burn Center
Ethics Committee Address
Street address City Postal code Country
1st of May Street, Ben Arous 2013, Tunisia Ben Arous 2013 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare resting pain scores (VAS) at H0, H2, H6, H12, and H24 between the PENG-like group and the placebo group H0, H2, H6, H12, H24
Secondary Outcome Perioperative opioid consumption (remifentanil and postoperative opioids) Measured intraoperatively and during the first 24 postoperative hours
Secondary Outcome Time to first analgesic request H0 until H 24 postoperatively
Secondary Outcome Incidence of adverse effects (nausea, vomiting, somnolence, hypoxemia, neurological symptoms) H0, H2, H6, H12, and H24 postoperatively
Secondary Outcome Motor function score (deltoid strength) H24 postoperative
Secondary Outcome Patient satisfaction H24 postoperatively
Secondary Outcome Rehospitalization and postoperative complications postoperative day 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Trauma and Burn Center of Ben Arous 1st of May Street, Ben Arous 2013, Tunisia Ben Arous 2013 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Trauma and Burn Center of Ben Arous 1st of May Street, Ben Arous 2013, Tunisia Ben Arous 2013 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Trauma and Burn Center of Ben Arous 1st of May Street Ben Arous 2013 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sabrine Ben Brahem sabrine.benbrahem@fmt.utm.tn 002726634140 Ezzahra
City Postal code Country Position/Affiliation
Ben Arous 2034 Tunisia Assistant Professor in Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Sabrine Ben Brahem sabrine.benbrahem@fmt.utm.tn 002726634140 Ezzahra
City Postal code Country Position/Affiliation
Ben Arous 2034 Tunisia Assistant Professor in Anesthesiology and Intensive Care
Role Name Email Phone Street address
Scientific Enquiries Sabrine Ben Brahem sabrine.benbrahem@fmt.utm.tn 002726634140 Ezzahra
City Postal code Country Position/Affiliation
Ben Arous 2034 Tunisia Assistant Professor in Anesthesiology and Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study, including demographic data, perioperative variables, pain scores, opioid consumption, and adverse events, will be available upon reasonable request to the principal investigator. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available beginning 6 months after publication of the study results and will remain available for 5 years. Access to de-identified participant data will be granted to researchers upon reasonable request and after approval by the principal investigator and the institutional ethics committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 03/07/2026 Administrative update following reviewer request for resubmission. No reviewer comments were available in the application; therefore, no scientific changes were required. Postoperative pain following shoulder arthroscopy, particularly rotator cuff repair, is often moderate to severe and may delay early rehabilitation while increase opioid consumption. The interscalene block remains the standard regional analgesic technique; however, it is frequently associated with phrenic nerve palsy and diaphragmatic dysfunction. The PENG-like (Pericapsular Nerve Group-like) block is a novel diaphragm-sparing regional anesthesia technique designed to target the sensory innervation of the anterior glenohumeral capsule while minimizing motor blockade. Preliminary evidence suggests that this approach may provide effective postoperative analgesia with fewer respiratory side effects. This prospective randomized triple-blind controlled study aims to evaluate the analgesic efficacy and safety of the PENG-like block in patients undergoing arthroscopic rotator cuff repair. The primary objective is to compare postoperative pain scores at rest between patients receiving an active PENG-like block and those receiving placebo. Secondary objectives include assessment of perioperative opioid consumption, time to first analgesic request, preservation of motor function, incidence of postoperative adverse events, patient satisfaction, and postoperative complications Postoperative pain following shoulder arthroscopy, particularly rotator cuff repair, is often moderate to severe and may delay early rehabilitation while increase opioid consumption. The interscalene block remains the standard regional analgesic technique; however, it is frequently associated with phrenic nerve palsy and diaphragmatic dysfunction. The PENG-like (Pericapsular Nerve Group-like) block is a novel diaphragm-sparing regional anesthesia technique designed to target the sensory innervation of the anterior glenohumeral capsule while minimizing motor blockade. Preliminary evidence suggests that this approach may provide effective postoperative analgesia with fewer respiratory side effects. This prospective randomized triple-blind controlled study aims to evaluate the analgesic efficacy and safety of the PENG-like block in patients undergoing arthroscopic rotator cuff repair. The primary objective is to compare postoperative pain scores at rest between patients receiving an active PENG-like block and those receiving placebo. Secondary objectives include assessment of perioperative opioid consumption, time to first analgesic request, preservation of motor function, incidence of postoperative adverse events, patient satisfaction, and postoperative complications. The study protocol remains unchanged. This update is submitted following the reviewers' request for resubmission.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 14/07/2026 Thank you for your comment. We have re-uploaded the complete ethics document. Please note that our Institutional Ethics Committee issues its approval by endorsing and signing the submitted application rather than by providing a separate approval letter on institutional letterhead. The uploaded document is the official ethics approval document issued by our committee. TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/07/2026 Thank you for your comment. We have re-uploaded the complete ethics document. Please note that our Institutional Ethics Committee issues its approval by endorsing and signing the submitted application rather than by providing a separate approval letter on institutional letterhead. The uploaded document is the official ethics approval document issued by our committee. TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/07/2026 Thank you for your comment. We have re-uploaded the complete ethics document. Thank you for your comment. The different dates correspond to different administrative stages of the ethics review process: April 2026: submission of the research protocol to the Institutional Ethics Committee. May 2026: date on which the Ethics Committee granted ethical approval. July 2026: administrative date corresponding to the final endorsement/issuance of the approved document. These dates refer to different steps of the ethics review process and do not represent multiple ethics approvals. TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf TRUE, Institutional Ethics Committee of the Ben Arous Trauma and Burn Center, 1st of May Street, Ben Arous 2013, Tunisia, Ben Arous, 2013, Tunisia, , 04 May 2026, 002779100500, ctgb@rns.tn, 41384_38627_4737.pdf