- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765278
Anterior Glenoid Nerve Block Versus Pericapsular Nerve Group Block Versus Interscalene Brachial Plexus Block for Postoperative Pain Management in Shoulder Arthroscopic Surgeries
Anterior Glenoid Nerve Block Versus Pericapsular Nerve Group (PENG) Block Versus Interscalene Brachial Plexus (ISB) Block for Postoperative Pain Management in Shoulder Arthroscopic Surgeries
Study Overview
Status
Conditions
Detailed Description
Major surgeries of the shoulder constitute some of the most commonly performed orthopedic procedures. They often result in moderate to severe postoperative pain thereby requiring a multimodal analgesic approach centered around peripheral nerve blocks.
Postoperative pain management is the part of shoulder surgery to improve patient satisfaction, start rehabilitation process rapidly and decrease for hospital stay.
Interscalene blocks (ISB) are well-studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia and post-operative pain management in shoulder surgeries.
A novel technique: pericapsular nerve group (PENG) block can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. In addition, PENG block targets articular branches with less motor effect compared with interscalene brachial plexus block providing anesthetic and analgesic effect with less complication and better and sooner ambulation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Serry, Master
- Phone Number: 00201002609476
- Email: mohamed.serry@med.asu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11591
- Recruiting
- Ain Shams University
-
Sub-Investigator:
- Amr E Abd El-Hamid, MD
-
Sub-Investigator:
- Ihab H Attia, MD
-
Sub-Investigator:
- Amr H Ali, MD
-
Sub-Investigator:
- Ossama M Farrag, MD
-
Contact:
- Mohamed Serry, Master
- Phone Number: 00201002609476
- Email: mohamed.serry@med.asu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 70 years.
- No sex predilection.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing shoulder arthroscopic surgeries.
Exclusion Criteria:
- Patient's refusal.
- Patients with a history of drug allergies to study drugs.
- Evidence of local infection at the site of injection.
- Inability to cooperate
- Neuromuscular pathology (example: - Multiple Sclerosis)
- Previous trauma or surgery to the shoulder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene brachial plexus block group
Patients will receive an Interscalene brachial plexus block.
|
Patients will receive an Interscalene brachial plexus block.
|
|
Experimental: Anterior glenoid nerve block group
Patients will receive an anterior glenoid nerve block.
|
Patients will receive an anterior glenoid nerve block.
|
|
Experimental: Pericapsular nerve group (PENG) block group
Patients will receive a pericapsular nerve group (PENG) block.
|
Patients will receive a pericapsular nerve group (PENG) block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for the rescue analgesia (time from the end of surgery to the first dose of pethidine administrated).
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total pethidine consumption
Time Frame: 24 hours postoperatively
|
All patients will receive intravenous pethidine (30mg) on demand [Visual Analogue Scale (VAS) score ≥3].
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Degree of pain will be assessed using visual analogue scale (VAS).
Each patient will be instructed about postoperative pain assessment with the VAS.
VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
VAS will be assessed at 0, 6, 12, and 24 hours postoperatively.
|
24 hours postoperatively
|
|
Length of hospital stay
Time Frame: Till discharge from hospital (Up to one week).
|
Length of hospital stay will be recorded from admission till the discharge from hospital.
|
Till discharge from hospital (Up to one week).
|
|
Time needed for the patient to freely move the operated limb
Time Frame: Postoperatively (Up to one week).
|
Time needed for the patient to freely move the operated limb will be recorded.
|
Postoperatively (Up to one week).
|
|
Degree of patients satisfaction
Time Frame: 24 hours postoperatively
|
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD195/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Bezmialem Vakif UniversityRecruitingPostoperative Pain ManagementTurkey
-
Pacira Pharmaceuticals, IncCompletedPostoperative Pain ManagementUnited States
Clinical Trials on Interscalene brachial plexus block
-
Sanliurfa Mehmet Akif Inan Education and Research...RecruitingCerebral Perfusion | Interscalene Block | Superficial Cervical Block | Shoulder SurgeriesTurkey (Türkiye)
-
Shanghai Jiao Tong University Affiliated Sixth...Enrolling by invitation
-
Seoul National University HospitalCompleted
-
Centre Hospitalier Universitaire VaudoisCompleted
-
Shanghai Tong Ren HospitalShanghai 6th People's HospitalNot yet recruitingProximal Humeral Fracture | Anesthesia, Regional | Diaphragmatic ParalysisChina
-
Tanta UniversityCompleted
-
Ataturk UniversityCompletedArthroscopic Shoulder SurgeryTurkey (Türkiye)
-
Rabin Medical CenterRecruitingRegional Anesthesia Techniques in Shoulder SurgeryIsrael
-
Erzurum Regional Training & Research HospitalCompletedShoulder PainTurkey (Türkiye)
-
Poznan University of Medical SciencesRecruitingOsteoarthritis ShoulderPoland