Effects of Interscalene Block on Visual Clarity in Arthroscopic Surgery

NCT06786013 | Completed

• 1 other identifier: 2024/5217
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Arthroscopic rotator cuff repair (RCR) has become the predominant technique for managing patients with full-thickness rotator cuff tears. Optimizing visual clarity is crucial for performing shoulder arthroscopy safely, precisely, and successfully. However, intraoperative bleeding remains the most significant factor impairing visual clarity. The interscalene brachial plexus block (ISB) technique is widely employed in shoulder joint and upper extremity surgeries. However, ISB may lead to hypertension due to the spread of local anesthetic to adjacent structures, such as the carotid sinus baroreceptors. Hypertension-induced microbleeding can obstruct the surgical field of view. Our hypothesis suggests that arthroscopic visual clarity may be compromised in awake patients receiving ISB for anesthesia. This study aims to compare the effects of interscalene brachial plexus block and general anesthesia on hemodynamic parameters and visual clarity in patients undergoing arthroscopic rotator cuff repair surgery.

Conditions

Rotator Cuff Syndrome

Keywords

interscalene block; visual clarity; Arthroscopic rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• Visual clarity during arthroscopic rotator cuff repair

  Visual clarity of the arthroscopic view will be assessed by the same surgeon (MO) using a Numeric Rating Scale (0 = very poor, 10 = excellent).

  1 day

Secondary Outcomes (2)

• Hemodynamic parameters

  1 day

• Visual analog scale (VAS) pain scores

  at 6,12, 18, 24 hours postoperatively

Study Arms (2)

Interscalene brachial plexus block (ISB)

The group that received ISB for arthroscopic rotator cuff repair anesthesia

General anesthesia group

The group that received general anesthesia for arthroscopic rotator cuff repair

Eligibility Criteria

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

Study Population

Patients scheduled to undergo arthroscopic rotator cuff repair

You may qualify if:

• Patients able to provide informed consent.
• Patients able to reliably report their symptoms to the research team.
• ASA physical status classification of 1-3.
• Scheduled to undergo arthroscopic rotator cuff repair surgery in the lateral decubitus position.

You may not qualify if:

• Contraindications to anesthesia.
• Patients under 18 years old.
• Cognitive impairment or communication barriers.
• BMI \> 40.
• Weight less than 50 kg or more than 100 kg.
• Psychiatric disorders.
• Chronic opioid therapy for pain.
• Severe liver, heart, or kidney failure.
• Hypertension (possibly severe, depending on the study context).
• Use of opioids for any reason.
• Revision shoulder surgery.
• Diaphragmatic paralysis on the opposite side of the planned intervention.
• Concurrent anticoagulation therapy or coagulopathy.
• Skin deformities or infections in the block area.
• Progressive neurological deficits affecting peripheral nerves.

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Alper Kilicaslan

Konya, Turkey (Türkiye)

Location

Related Publications (2)

• Gianesello L, Magherini M, Pavoni V, Horton A, Nella A, Campolo MC. The influence of interscalene block technique on adverse hemodynamic events. J Anesth. 2014 Jun;28(3):407-12. doi: 10.1007/s00540-013-1748-8. Epub 2013 Nov 21.

  PMID: 24258467 RESULT

• Bildik C, Pehlivanoglu T. Arthroscopic rotator cuff repair performed with intra-articular tranexamic acid: could it provide improved visual clarity and less postoperative pain? A prospective, double-blind, randomized study of 63 patients. J Shoulder Elbow Surg. 2023 Feb;32(2):223-231. doi: 10.1016/j.jse.2022.10.007. Epub 2022 Nov 18.

  PMID: 36403924 RESULT

Study Officials

• Alper KILICASLAN, Prof

  Konya Necmettin Erbakan Universty Medical Faculty /Türkiye

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alper Kılıçaslan, MD, Prpf, Specialist in Anesthesiology and Reanimation.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 22, 2025
• Study Start: January 17, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)