Shoulder Anterior Capsular Block and Interscalene Brachial Plexus Block for Shoulder Arthroscopy

NCT05727345 | Unknown

• 1 other identifier: 142-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to reveal a comparison between interscalene brachial plexus block and shoulder anterior capsular block with respect to their efficacy on pain relief during perioperative anesthetic management. As intraoperative hemodynamic stability is an important factor for surgeons to achieve better outcomes because of its effect on the quality of arthroscopic visualization for shoulder arthroplasty, the investigators will also observe the effects of this matter. 50 patients scheduled for elective surgery will be randomized by closed envelope method into two groups (n=20) receiving either interscalene brachial plexus block or shoulder anterior capsular block preoperatively. Each group receives standardized general anesthesia and perioperative pain management protocol. Data to be recorded are numeric rating scales, intraoperative and postoperative analgesic use, intraoperative hemodynamic parameters, and arthroscopic visualization score. Moreover, block performance time, motor block, and side effects or complications will be noted.

Conditions

Shoulder Arthroscopy; Interscalene Brachial Plexus Block; Shoulder Anterior Capsular Block; Rotator Cuff Rupture

Keywords

Shoulder arthroscopy; Postoperative pain; Interscalene brachial plexus block; Shoulder anterior capsular block; Hemodynamic stability

Outcome Measures

Primary Outcomes (2)

• Numeric rating scale (NRS)

  Numeric rating scale (NRS) worst pain imaginable as 10 points to zero pain. Verbal rating scale (VRS): no pain; slight pain; moderate pain; severe pain; unbearable pain

  2 days

• Analgesic drug used

  The total amount of analgesic drug used during the postoperative follow-up

  2 days

Secondary Outcomes (3)

• heart rate

  Intraoperative

• Arthroscopic visualization score

  Intraoperative

• blood pressure

  Intraoperative

Study Arms (2)

Interscalene

ACTIVE COMPARATOR

Right after general anesthesia induction and patient intubation, the patient will be placed in the semi-sitting position. Following sterile skin preparation, an interscalene block will be performed by the same anaesthesiologist under ultrasound guidance with an in-plane posterior approach approximately between C6-C7 nerve roots through a 22-gauge 50-mm insulated stimulating needle (StimuPlex Nanoline, Braun). Neurostimulation with an initial current of 0,5 mA, pulse width of 100ms, and a frequency of 2 Hz will be used as protection for intraneural injection, once the needle tip is in proximity to the brachial plexus. 15 mL local anesthetic solution (0.375 % bupivacaine anesthetic solution of 10 mL and 2 % lidocaine anesthetic solution of 5 mL) will be observed to disperse within the interscalene space.

Procedure: Interscalene brachial plexus block

SHAC

EXPERIMENTAL

Right after general anesthesia induction and patient intubation, the patient will be placed in the semi-sitting position with the arm in extension and abduction. Following sterile skin preparation, a SHAC block will be performed by the same anaesthesiologist under ultrasound guidance by visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia and glenohumeral pericapsular space. A 22-gauge 50-mm insulated stimulating needle (StimuPlex Nanoline, Braun) will be used to give 1-3 mL of 5% Dextrose for the correct location and then 15 mL local anesthetic solution will be divided into 7,5 mL (0.375 % bupivacaine 5 mL and 2 % lidocaine 2,5 mL) for each target points as interfascial space and pericapsular space.

Procedure: Shoulder anterior capsular block

Interventions

Interscalene brachial plexus block PROCEDURE

Preoperative ultrasound-guided interscalene brachial plexus block application

Interscalene

Shoulder anterior capsular block PROCEDURE

Preoperative ultrasound-guided shoulder anterior capsular(SHAC) block application

SHAC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with rotator cuff rupture and admitted to receiving arthroscopic cuff repair surgery
• American Society of Anaesthesiologists (ASA) Physical Status classification I to III
• Patients who will give informed consent to peripheral nerve blocks

You may not qualify if:

• Refusal to participate in the study
• History of neurologic deficits or neuropathy affecting the brachial plexus
• Infection at the site of the block application
• Coagulopathy
• Pre-existing respiratory dysfunction
• Allergy to local anesthetics
• Uncooperated patients who cannot reliably answer verbal pain evaluation

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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: 32987232 BACKGROUND

• Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.

  PMID: 31490292 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Berna Caliskan, MD

  Haseki Training and Research Hospital Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Berna Caliskan, MD

CONTACT

+905067108770; caliskan.b@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After surgery, all patients will be followed by the same orthopaedist who is blind to the patient groups. Also, the patients themselves cannot know their groups as well. Only the investigator opens the opaque closed envelope and the same anesthesiologist, the investigator will perform blocks and will be the only one knowing study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once the investigator chose from the opaque envelopes which group the patient will be included, interscalene brachial plexus block will be applied for Group A and shoulder anterior capsular block will be applied for Group B. All other interventions will be standardized.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 14, 2023
• Study Start: June 30, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)