Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy
Primary Purpose
Pericapsular Nerve Block, Interscalene Nerve Block, Shoulder Arthroscopy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The pericapsular nerve group
Interscalene brachial plexus block
Sponsored by
About this trial
This is an interventional treatment trial for Pericapsular Nerve Block
Eligibility Criteria
Inclusion Criteria: Body mass index < 40 kg/m2 American Society of Anesthesiologists (ASA) physical status I-II posted for elective shoulder arthroscopy Exclusion Criteria: Known allergy to local anesthetics allergy to all opioid medications diagnostic shoulder arthroscopic procedures patients with chronic opioids use and coagulopathy
Sites / Locations
- Mohammed Fouad Mohamed AlgyarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
The pericapsular nerve group
Interscalene group
Arm Description
patients received Ultrasound guided The pericapsular nerve group block using 20 ml of bupivacaine 0.5%
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia.
Outcomes
Primary Outcome Measures
Asses The postoperative opioid consumption
the postoperative opioid consumption during the procedure
Secondary Outcome Measures
Full Information
NCT ID
NCT05788367
First Posted
January 12, 2023
Last Updated
October 1, 2023
Sponsor
Kafrelsheikh University
1. Study Identification
Unique Protocol Identification Number
NCT05788367
Brief Title
Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy
Official Title
Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.
Detailed Description
Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.
Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.
Interscalene brachial plexus blocks (ISBPBs) are often used to provide perioperative analgesia and anesthesia for shoulder surgery. They target nerve roots C4-C6 and thereby provide regional analgesia to the shoulder and upper arm. Although ISBPBs are often performed in combination with general anesthesia (GA) to enhance postoperative analgesia, they are also sometimes used as a sole means of anesthesia.
The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, and for analgesia after elective hip surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericapsular Nerve Block, Interscalene Nerve Block, Shoulder Arthroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The pericapsular nerve group
Arm Type
Active Comparator
Arm Description
patients received Ultrasound guided The pericapsular nerve group block using 20 ml of bupivacaine 0.5%
Arm Title
Interscalene group
Arm Type
Active Comparator
Arm Description
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
The pericapsular nerve group
Intervention Description
patients received Ultrasound guided pericapsular nerve group block using 20 ml of bupivacaine 0.5%
Intervention Type
Procedure
Intervention Name(s)
Interscalene brachial plexus block
Intervention Description
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia
Primary Outcome Measure Information:
Title
Asses The postoperative opioid consumption
Description
the postoperative opioid consumption during the procedure
Time Frame
24 hours postoperatively
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:
Body mass index < 40 kg/m2
American Society of Anesthesiologists (ASA) physical status I-II
posted for elective shoulder arthroscopy
Exclusion Criteria:
Known allergy to local anesthetics
allergy to all opioid medications
diagnostic shoulder arthroscopic procedures
patients with chronic opioids use and coagulopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed F Algyar, MD
Phone
00201111645345
Ext
047
Email
mohammad.algaiar@med.kfs.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed F Algyar, MD
Organizational Affiliation
Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammed Fouad Mohamed Algyar
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
ZIP/Postal Code
33516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed F Algyar, MD
Phone
00201111645345
Ext
047
Email
mohammad.algaiar@med.kfs.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be provided under a reasonable request from the corresponding author
IPD Sharing Time Frame
One year after the end of the study
Learn more about this trial
Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy
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