Ultrasound-guided Interscalene Block Versus Infraspinatus-Teres Minor Plane Block in Shoulder Arthroscopy

NCT07016386 | Active Not Recruiting DMC

• 1 other identifier: 2022/0126
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of ultrasound-guided Interscalene block (ISB) versus Infraspinatus-Teres minor (ITM) interfacial plane block in shoulder arthroscopic surgery. A prospective, randomized clinical trial will be conducted with 46 patients. Approval was obtained from the Medical Ethics Committee (2022/0126), and written informed consent will be collected from all participants. Patients aged 20-70, ASA I-II, scheduled for arthroscopic shoulder surgery will be divided before the induction of general anesthesia (GA) into two groups: Group A: will receive the ultrasound guided ISB technique with a 15ml solution of 7.5ml lidocaine 2% and 7.5ml bupivacaine 0.5% be injected between the anterior and middle scalene muscles. Group B: will receive the ultrasound guided ITM block with the same anesthetic solution be injected between the infraspinatus and teres minor muscles. Researchers will examine the following outcomes;

1. 1.Primary outcome measure: Efficacy of analgesia by Pain score; will be measured by Numerical Rating Scale (NRS) score (0=no pain,1-3=mild,4-6=moderate,7-9=sever,10=most sever) at postoperative 12 hour.
2. 2.Secondary outcome measures:
3. 3.Duration of analgesia, starting from recovery from general anesthesia (GA) to 1st time giving the patient rescue analgesia ( measured by NRS pain score at 0, 6 ,12, 18 and 24 postoperative hours)
4. 4.Risk of complications from techniques
5. 5.Patient satisfaction after surgery.
6. 6.Rescue analgesic consumption
7. 7.Hemodynamics monitoring; measurements of heart rate and mean arterial blood pressure before induction of anesthesia and every 15 minutes during surgery till end of surgery

Conditions

Pain; Pain Management; Pain Management in Postoperative Care

Keywords

Ultrasound guided,; interscaline block,; versus infraspinatus-teres minor block; shoulder arthroscopy.

Outcome Measures

Primary Outcomes (1)

• Efficacy of analgesia

  Will be measured by pain score at 12 hours postoperatively using the Numerical Rating Scale (NRS) (0-10; with 0 means no pain and 10 means most intolerable pain)

  at 12 hours postoperatively

Secondary Outcomes (7)

• Duration of analgesia

  Starting from recovery from general anesthesia (GA) to 1st time giving the patient rescue analgesia,

• Hemodynamics (heart rate)

  before induction of anesthesia and every 15 minutes during surgery till end of surgery

• Total intraoperative analgesic consumption (fentanyl).

  During surgery; from induction of anesthesia to end of surgery.

• Patient satisfaction

  for the first postoperative 24 hours

• Complications of the techniques

  From time of injection to the end of first 24 hours postoperative

Study Arms (2)

Group A : Ultrasound guided Interscalene block (ISB) technique

ACTIVE COMPARATOR

Interscalene block (ISB) technique, patients will be place in the supine position and the patient's head facing away from the side to be blocked. The Ultrasound probe will be applied in sterile fashion on the supraclavicular fossa to find the brachial plexus division lateral to the subclavian artery. Then, the probe will be traced cephalad to the C5-C6 root and interscalene muscles at the level of the cricoid cartilage

Procedure: Group A: will receive an ultrasound-guided interscalene block (ISB)

Group B: Ultrasound guided Infraspinatus-teres minor (ITM) interfacial plane block technique

EXPERIMENTAL

Infraspinatus-teres minor (ITM) interfacial plane block technique, Patients will be placed in the lateral position, and a pillow will be wedged under the anterior shoulder and upper arm. The Ultrasound probe will be applied in sterile fashion and put angled obliquely, to be perpendicular to the direction of muscles to obtain the transverse scan of muscles for the ITM block. After palpation of the posterolateral corner of the acromion, the muscle-tendon units of infraspinatus (IS) and teres minor (Tm) on the humeral head will be identified below the corner. At this time, the probe will be moved slightly caudad to identify the borders of Tm. Once the IS and Tm on the humeral head area identified, by moving the probe medio caudally, the interfascial structure of the IS and Tm could be traced on the posterior surface area of the neck of the scapula.

Procedure: Group B:will receive an ultrasound-guided infraspinatus-teres minor (ITM) interfacial plane block

Interventions

Group A: will receive an ultrasound-guided interscalene block (ISB) PROCEDURE

Group A: will receive an ultrasound-guided interscalene block (ISB) using a 15ml mixture of lidocaine (7.5ml 2%) and bupivacaine (7.5ml 0.5%).

Group A : Ultrasound guided Interscalene block (ISB) technique

Group B:will receive an ultrasound-guided infraspinatus-teres minor (ITM) interfacial plane block PROCEDURE

Group B:will receive an ultrasound-guided infraspinatus-teres minor (ITM) interfacial plane block using a 15ml mixture of lidocaine (7.5ml 2%) and bupivacaine (7.5ml 0.5%).

Group B: Ultrasound guided Infraspinatus-teres minor (ITM) interfacial plane block technique

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 20 to 60,
• ASA classification I or II,
• scheduled for arthroscopic shoulder surgery,
• will be randomized 1:1 into two groups before the induction of general anesthesia (GA)

You may not qualify if:

• Patients who refuse participation.
• Have allergies to local anesthetics.
• Phrenic nerve dysfunction.
• Chronic opioid use.
• ASA III or higher classification.
• Coagulopathy.
• Severe chronic obstructive pulmonary disease.
• Local infection at the injection site

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Souad Kafafi University Hospital (SKUH), Faculty of medicine, Misr University for Science and Technology (MUST)

Giza, Giza Governorate, 15525, Egypt

Location

Related Publications (1)

• Hewson DW, Oldman M, Bedforth NM. Regional anaesthesia for shoulder surgery. BJA Educ. 2019 Apr;19(4):98-104. doi: 10.1016/j.bjae.2018.12.004. Epub 2019 Feb 6. No abstract available.

  PMID: 33456877 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Interventions

SLC22A18 protein, human

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Mohammed Hany Kamal, Prof. of anesthesia and pain

  Misr University for Science and Technolog

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants, care providers and outcome assessor will be blind regarding the procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, SICU & Pain management

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 11, 2025
• Study Start: June 15, 2025
• Primary Completion: January 20, 2026
• Study Completion: January 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01/06//2025 to 31/5/2026
• Access Criteria: Researchers: Who: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures. How: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals. Regulatory Authorities: Who: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications. Data Sharing Initiatives: Who: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases. Public and Patient Advocacy Groups: Who: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.

Locations

EG (1)