NCT06827912

Brief Summary

Due to the development and easy availability of ultrasonography devices, regional nerve blocks are routinely used by anesthesiologists among multimodal analgesia techniques. Interscalene and supraclavicular nerve blocks are the leading regional anesthesia techniques for shoulder surgeries. However, due to the phrenic nerve involvement and loss of motor function in the upper extremity in these block techniques, new nerve blocks have been developed and used for postoperative analgesia. One of the blocks that has been used increasingly in shoulder region surgeries and does not cause phrenic nerve involvement is the shoulder anterior capsule block (SHAC). The aim of this study is to compare the postoperative analgesic effects of interscalene nerve block and SHAC block in patients undergoing arthroscopic rotator cuff repair surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

April 9, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

February 10, 2025

Last Update Submit

April 8, 2025

Conditions

Keywords

Pain ManagementInterscalene BlockShoulder Anterior Capsular BlockPericapsuler nerve group blockSHACPENGRotator cuff repair

Outcome Measures

Primary Outcomes (1)

  • Postoperative 12th hour pain score

    Postoperative 12th hour pain score (will be evaluated with Numeric Rating Scale) Higher scores indicate worse condition

    Postoperative 12th hour

Secondary Outcomes (6)

  • Postoperative 1, 2, 4, 8, 12, 16, 24, 48 hours pain score

    Postoperative 1, 2, 4, 8, 12, 16, 24, 48 hours

  • Amount of opioid consumption

    in the first 24 hours postoperatively

  • Complications related to opioid use

    in the first 24 hours postoperatively

  • Elephant flexion motor strength evaluation

    in the first 24 hours postoperatively

  • Surgeon satisfaction level with Likert scale

    during surgery

  • +1 more secondary outcomes

Study Arms (2)

Interscalene Block Group

ACTIVE COMPARATOR
Procedure: Shoulder Anterior Capsule Block

SHAC Block Group

ACTIVE COMPARATOR
Procedure: Interscalene Nerve Block

Interventions

After sterile conditions are provided with the patient in the supine position, the brachial plexus will be identified in the supraclavicular fossa above the clavicle with ultrasonography. The transducer will be directed cephalad and 20 cc 0.5% bupivacaine will be applied to the interscalene space with a 50 mm block needle from the point where the C 5-6-7 nerve roots give the impression of a rosary bead between the anterior and medial scalene muscles.

SHAC Block Group

In pericapsular nerve block application, the patient will be placed in a supine position and the arm will be externally rotated and abducted to 45 degrees. After sterile conditions are provided, the humerus head, the tendon of the subscapularis muscle and the deltoid muscle above it will be identified with ultrasonography. 15 cc of 0.5% bupivacaine will be injected into the interfascial space between the deltoid muscle and the subscapularis muscle with a 22gauge 50 mm block needle. Then, the block needle will be directed deep into the subscapularis muscle and another 5 cc of 0.5% bupivacaine will be injected under the subscapularis muscle.

Interscalene Block Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2 patients who will undergo arthroscopic rotator cuff repair,
  • Patients between the ages of 18-75

You may not qualify if:

  • Allergy to local anesthetics
  • Infection at the block site
  • Neuropathy in the involved extremity
  • History of chronic opioid use
  • Revision surgery
  • History of hepatic and renal failure
  • History of peripheral neuropathy
  • History of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital

Amasya, Amasya, 05200, Turkey (Türkiye)

Location

Related Publications (4)

  • Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available.

    PMID: 32987232BACKGROUND
  • 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: 34118263BACKGROUND
  • Galluccio F, Fajardo Perez M, Yamak Altinpulluk E, Hou JD, Lin JA. Evaluation of Interfascial Plane and Pericapsular Nerve Blocks to the Shoulder Joint: A Preliminary Analysis of Shoulder Anterior Capsular Block. Pain Ther. 2021 Dec;10(2):1741-1754. doi: 10.1007/s40122-021-00326-0. Epub 2021 Oct 20.

    PMID: 34669181BACKGROUND
  • Cam BM, Tuzen AS, Duran HT, Akdogan MA. Comparison of interscalene block versus shoulder anterior capsule block for postoperative pain management in rotator cuff surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Sep 29;25(1):459. doi: 10.1186/s12871-025-03351-0.

MeSH Terms

Conditions

Agnosia

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

February 20, 2025

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 9, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations