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Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05788367
Recruitment Status : Not yet recruiting
First Posted : March 28, 2023
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Fouad Algyar, Kafrelsheikh University

Study Description
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Brief Summary:
The aim of this study is to compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.

Condition or disease Intervention/treatment Phase
Pericapsular Nerve Block Interscalene Nerve Block Shoulder Arthroscopy Procedure: The pericapsular nerve group Procedure: Interscalene brachial plexus block Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy: A Randomized Controlled Study
Estimated Study Start Date : July 15, 2023
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : July 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: The pericapsular nerve group
patients received Ultrasound guided The pericapsular nerve group block using 20 ml of bupivacaine 0.5%
 Procedure: The pericapsular nerve group
patients received Ultrasound guided pericapsular nerve group block using 20 ml of bupivacaine 0.5%
Active Comparator: Interscalene group
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia.
 Procedure: Interscalene brachial plexus block
patients will receive interscalene brachial plexus block using 15 ml of bupivacaine 0.5% before induction of general anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. Asses The postoperative opioid consumption [ Time Frame: 24 hours postoperatively ]
    the postoperative opioid consumption during the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05788367


Contacts
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Contact: Mohammed F Algyar, MD 00201111645345 ext 047 mohammad.algaiar@med.kfs.edu.eg

Locations
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Egypt
Mohammed Fouad Mohamed Algyar
Kafrelsheikh, Egypt, 33516
Contact: Mohammed F Algyar, MD    00201111645345 ext 047    mohammad.algaiar@med.kfs.edu.eg   
Sponsors and Collaborators
Kafrelsheikh University
Investigators
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Principal Investigator: Mohammed F Algyar, MD Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
More Information
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Responsible Party: Mohamed Fouad Algyar, Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT05788367    
Other Study ID Numbers: MKSU 50-12-7
First Posted: March 28, 2023    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be provided under a reasonable request from the corresponding author
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: One year after the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations