NCT06529393

Brief Summary

The aim of the study is to compare the post-operative analgesic effect of Shoulder anterior capsule (SHAC) block with Suprascapular nerve block for arthroscopic shoulder surgery with a hypothesis that both Shoulder anterior capsule (SHAC) block and Suprascapular nerve block are effective in providing postoperative analgesia for arthroscopic shoulder surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

July 15, 2024

Last Update Submit

February 21, 2025

Conditions

Keywords

SHAC Block

Outcome Measures

Primary Outcomes (1)

  • effect on postopeartive pain after shoulder arthrscopy

    the pain intensity assessment at rest and on coughing using Numerical Rating Scale (NRS) This will measure pain intensity from 0 to 10 , 0: no pain 3:mild pain 7:moderate pain 10:severe pain

    baseline

Secondary Outcomes (3)

  • -inceidence of (POVN) 24 hours postoperatively -Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)

    first 24 hours

  • -Time of the first opioid request

    first 24 hour

  • -Block related complications during and after block procedure till 24 hours postoperatively (LAST, pneumohorax and vascular puncture during block procedure)

    first 24 hours

Study Arms (2)

SHAC block group

ACTIVE COMPARATOR

For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .

Procedure: SHAC block

Suprascapular nerve block group

ACTIVE COMPARATOR

Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.

Procedure: suprascapular nerve block

Interventions

SHAC blockPROCEDURE

with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, the investigators also reach the intra-articular space .

Also known as: shoulder anterior capsule block
SHAC block group

Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.

Suprascapular nerve block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years.
  • Body mass index (BMI)of 18-35Kg /m2.
  • Patients with American society of anesthesiologist (ASA) physical status \| / \|\|.
  • Patients scheduled for elective Arthroscopic Shoulder Surgery.
  • Both sexes, males and females.

You may not qualify if:

  • Patient refusal.
  • Allergy to local anaesthetics.
  • Infection at the site of injection .
  • Coagulopathy.
  • Chronin pain syndromes.
  • Prolonged opioid medication
  • Patients who received any analgesia 24 h before surgery.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Trauma Hospital

Asyut, Egypt

Location

Related Publications (5)

  • Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.

    PMID: 20565394BACKGROUND
  • Paxton ES, Backus J, Keener J, Brophy RH. Shoulder arthroscopy: basic principles of positioning, anesthesia, and portal anatomy. J Am Acad Orthop Surg. 2013 Jun;21(6):332-42. doi: 10.5435/JAAOS-21-06-332.

    PMID: 23728958BACKGROUND
  • Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.

    PMID: 15271745BACKGROUND
  • Basat HC, Ucar DH, Armangil M, Guclu B, Demirtas M. Post operative pain management in shoulder surgery: Suprascapular and axillary nerve block by arthroscope assisted catheter placement. Indian J Orthop. 2016 Nov-Dec;50(6):584-589. doi: 10.4103/0019-5413.193474.

    PMID: 27904211BACKGROUND
  • Brenner W, Bohuslavizki KH, Wolf H, Sippel C, Clausen M, Henze E. Radiotherapy with iodine-131 in recurrent malignant struma ovarii. Eur J Nucl Med. 1996 Jan;23(1):91-4. doi: 10.1007/BF01736995.

    PMID: 8586108BACKGROUND

MeSH Terms

Conditions

Shoulder PainPain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Mohamed S Hassanen, professor

    Assuit university Hospital

    STUDY CHAIR
  • Rana EA Ibrahim, Resident

    Assuit university Hospital

    PRINCIPAL INVESTIGATOR
  • Ayman Abdel Khalek, Ass professor

    Assuit university Hospital

    STUDY DIRECTOR

Central Study Contacts

Rana EA Ibrahim, Resident

CONTACT

Ayman M Abdel Khalek, Ass professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: For the SHAC block, with the patient in a beach-chair position and with the arm in extension,With external rotation and abduction,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the space where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected By injecting the pericapsular space, we reach the terminal articular branches indistinctly from their origin. For suprascapular nerve block : Patients will be placed in lateral position until supraspinatus or infraspinatus muscle contractions were elicited. Following negative aspiration,A 21G 10-cm needle will be inserted using an in-plane approach .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed .A volume of 15 mL of a mixture of 2% lidocaine (5 mL) and 0.5% levobupivacaine (10 mL) was injected.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 31, 2024

Study Start

March 1, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

method outcome

Locations