A Comparative Study Between Ultrasound Guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries: Double Blinded Randomized Clinical Trial

NCT05982951 | Active Not Recruiting DMC

• 1 other identifier: GeneralCTHI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder arthroscopic surgeries are one of the most common procedures performed daily in our practice. The arthroscopic techniques offer a less invasive option as Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of the full range of motion of the shoulder. Open techniques Shoulder procedures are performed arthroscopically nowadays with fewer complications compared with open surgery. Indications of shoulder arthroscopy are expanding and include biceps tears, labral tears, rotator muscle tears, subacromial impingements chondral injuries, loose bodies, early degenerative changes, adhesive capsulitis, shoulder instability and acromioclavicular osteoarthritis. There are many regional anesthetic techniques used to control perioperative pain during arthroscopic procedures. Interscalene block results in effective shoulder surgery analgesia, but it is associated with various complications such as diaphragmatic paralysis due to the high incidence of phrenic nerve block. The suprascapular nerve block combined with the axillary nerve block is non-inferior to conventional inter-scalene block except for the early recovery period with the advantage of lower incidence of dyspnea and discomfort. . In a cadaveric anatomical study that the posterosuperior quadrant and the posteroinferior quadrant of the GHJ were innervated by the suprascapular nerve and the axillary nerve respectively. While the anterosuperior quadrant portion of the joint is sensory supplied by the subscapularis superior branch and the anteroinferior by the main branch of the axillary nerve. These anatomical data the possibility of a new block targeting the GHJ sensory branches. It was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the GHJ. Recently, the pericapsular nerve group block of the shoulder joint as described in a case series including two cases underwent a humeral neck fracture fixation and Bankart arthroscopic repair with promising anesthesia and analgesia in selected shoulder surgeries.

Conditions

Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries; Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia (time to first rescue analgesia) minutes

  Postoperative pain will be assessed using 100 millimeter vertical visual analog score (VAS) where (1-3) no pain, \>3- 6) mild pain, and (\>6 severe pain). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram adequate with 5 minutes intervals till VAS be less than 30 mm or exceeds the safety dose of 30 mg in 4 hours.

  24 hours after surgery

Secondary Outcomes (7)

• Total morphine consumption milligrams

  24 hours after surgery

• Total fentanyl consumptions microgram

  Intraoperative period

• intraoperative hemodynamics

  Intraoperative period

• length of stay in hospital hours

  24 hours postoperative

• postoperative sedation

  Immediate postoperative period

Study Arms (2)

Shoulder PENG block group

ACTIVE COMPARATOR

Ultrasound-guided peri-capsular nerve block of the shoulder with 20ml of 0.25% bupivacaine between the supraspinatus muscle and deltoid muscle.

Procedure: Shoulder PENG block

Shoulder block

ACTIVE COMPARATOR

ultrasound guided axillary nerve block and suprascapular nerve block posterior approach with 10 ml 0.25% bupivacaine (total 20ml)

Procedure: Shoulder PENG block

Interventions

Shoulder PENG block PROCEDURE

Ultrasound guided insertion of a needle between subscapularis tendon and deltoid with injection of 10 mi 0.25% bupivacaine after confirming right plane of injection

Also known as: Shoulder Block

Shoulder PENG block group; Shoulder block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I - II
• Age between 18 - 60
• unilateral elective shoulder arthroscopic surgery

You may not qualify if:

• Patient refusal
• Altered mental status or un-cooperative patients
• Hypersensitivity to local anesthetics
• Bleeding disorders
• receiving antiplatelet or anticoagulant drugs
• local infection at the site of local injection
• Intra articular infections

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

Ahmed Maher Teaching Hospital

Cairo, 11617, Egypt

Location

Related Publications (9)

• Rockwood CA Jr. Shoulder arthroscopy. J Bone Joint Surg Am. 1988 Jun;70(5):639-40. No abstract available.

  PMID: 3392055 BACKGROUND

• Severud EL, Ruotolo C, Abbott DD, Nottage WM. All-arthroscopic versus mini-open rotator cuff repair: A long-term retrospective outcome comparison. Arthroscopy. 2003 Mar;19(3):234-8. doi: 10.1053/jars.2003.50036.

  PMID: 12627146 BACKGROUND

• Farmer KW, Wright TW. Shoulder arthroscopy: the basics. J Hand Surg Am. 2015 Apr;40(4):817-21. doi: 10.1016/j.jhsa.2015.01.002. Epub 2015 Feb 26.

  PMID: 25726045 BACKGROUND

• Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.

  PMID: 27941477 BACKGROUND

• Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.

  PMID: 29659438 BACKGROUND

• Tran J, Peng PWH, Agur AMR. Anatomical study of the innervation of glenohumeral and acromioclavicular joint capsules: implications for image-guided intervention. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100152. doi: 10.1136/rapm-2018-100152. Online ahead of print.

  PMID: 30635516 BACKGROUND

• Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.

  PMID: 34118263 BACKGROUND

• Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019 May;63(5):382-387. doi: 10.4103/ija.IJA_65_19.

  PMID: 31142882 BACKGROUND

• Grosh T, Elkassabany NM. Enhanced Recovery After Shoulder Arthroplasty. Anesthesiol Clin. 2018 Sep;36(3):417-430. doi: 10.1016/j.anclin.2018.04.006.

  PMID: 30092938 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The block will be performed by one investigator who is not participating in either data collection or analysis. Also the patient will be blinded .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow lecturer of Anaesthesia

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 5, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)