- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06790732
Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
The Effect of Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain control after shoulder surgery is challenging, and poor pain management is invariably reflected in poor outcomes, with longer hospitalization and recovery time. The difficulty in reducing pain due to the complexity of shoulder innervation leads to conducting studies to explore selective axillary nerve blocks with a posterior approach or from the axillae.
The peri-capsular nerve group (PENG) block is a regional anesthetic technique. It can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. It targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for better physical therapy, and earlier discharge.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for unilateral shoulder arthroscopic surgery.
Exclusion Criteria:
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index> 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
- Coagulation disorder.
- Major cardiac, renal, or hepatic diseases.
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 |
|---|---|
|
Sham Comparator: Control Group
Patients received sham PENG block (just 1mL saline).
|
Patients received sham PENG block (just 1mL saline).
|
|
Experimental: PeriCapsular Nerve Group Block (PENG) Group
Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).
|
Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the first request of rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request of rescue analgesia was recorded from the end of the surgery till first dose of morphine administrated.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
The degree of pain was assessed using the Numerical Rating Scale (NRS) Pain score (metric score from 0 to 10 where 0 = no pain and 10 = maximal pain).
NRS was recorded at PACU and 2, 4, 6, 8, 12, 16, 20, and 24 h postoperative.
|
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
If patient numeric rating score was more than 3, patients received 3 mg morphine slowly intravenously.
Morphine injection was repeated whenever required.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Antineoplastic Agents
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antiemetics
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Dexamethasone
- Bupivacaine
Other Study ID Numbers
- 36264MS117/3/23
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.
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