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Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery

Primary Purpose

Rotator Cuff, Bankert Repair

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Interscalene versus PENG Block
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA physical status class I - II patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery Exclusion Criteria: Patients with respiratory disease, renal or hepatic insufficiency, infection of the skin in the puncture area, coagulopathy, allergy against any of the drugs to be used (bupivacaine), neuromuscular disease, obesity (body mass index, BMI >30), previous analgesic medication, chronic pain, and previously known neurological pathologies or central nervous system disorders

Sites / Locations

  • Rehab A. Abd El-AzizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. Interscalene group

2. PENG Block

Arm Description

Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).

Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).

Outcomes

Primary Outcome Measures

visual analogue scale
visual analogue scale to assess the analgesic efficacy of ultrasound-guided intrscalene block versus PENG Block

Secondary Outcome Measures

Full Information

First Posted
December 10, 2022
Last Updated
December 19, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05668533
Brief Title
Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery
Official Title
Comparing Postoperative Analgesic Efficiency of Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Early postoperative pain after arthroscopic shoulder surgery is a major problem for patients and orthopedic surgeons. Adequate pain control is vital for all aspects of patient recovery; including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes. (1) Single analgesic regimens are not always effective in controlling moderate to severe postoperative pain. Therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.(2) Regional techniques form an integral part of multimodal analgesia of most of the enhanced recovery protocols and aid in minimizing the requirements of opioids to control acute postoperative pain which results in better, faster recovery and better satisfaction. Also, it is well known that sufficient management of acute pain is essential to prevent its transition to chronic pain.(3) The use of ultrasound guidance and its incorporation into the practice of regional anesthesia has dramatically improved the safety and success of perioperative care.(4) Ultrasound guided regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia. To ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked. Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. However, the hemi-diaphragmatic paresis that may occur after the block has led to the search for an alternative to the ISB block. (5) Pericapsular nerve group block (PENG) 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. The block of this area did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. It was demonstrated that the PENG block may be safely applied for both partial anesthesia and analgesia.(6)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff, Bankert Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Interscalene group
Arm Type
Active Comparator
Arm Description
Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
Arm Title
2. PENG Block
Arm Type
Active Comparator
Arm Description
Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
Intervention Type
Diagnostic Test
Intervention Name(s)
Interscalene versus PENG Block
Intervention Description
Interscalene group: Patients received ipsilateral ultrasound-guided interscalene nerve after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg). PENG Block: Patients received ultrasound-guided PENG block after induction of general anesthesia using bupivacaine 0.25% (0.5 mL/kg).
Primary Outcome Measure Information:
Title
visual analogue scale
Description
visual analogue scale to assess the analgesic efficacy of ultrasound-guided intrscalene block versus PENG Block
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status class I - II patient who will be scheduled for an elective unilateral arthroscopic shoulder surgery Exclusion Criteria: Patients with respiratory disease, renal or hepatic insufficiency, infection of the skin in the puncture area, coagulopathy, allergy against any of the drugs to be used (bupivacaine), neuromuscular disease, obesity (body mass index, BMI >30), previous analgesic medication, chronic pain, and previously known neurological pathologies or central nervous system disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab A. Abd El- Aziz, ass. prof
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
Facility Information:
Facility Name
Rehab A. Abd El-Aziz
City
Alexandria
ZIP/Postal Code
000000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rehab a. abd ei-aziz, ass. prof
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com

12. IPD Sharing Statement

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Intrscalene Block Versus Pericapsular Nerve Group Block for Arthroscopic Shoulder Surgery

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