Ultrasound-guided Interscalene Block Versus Infraspinatus-Teres Minor Plane Block in Shoulder Arthroscopy
NCT07016386 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-07-23
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. 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. Secondary outcome measures:
1. 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)
2. Risk of complications from techniques
3. Patient satisfaction after surgery.
4. Rescue analgesic consumption
5. 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
Interventions
- PROCEDURE
-
Group A: will receive an ultrasound-guided interscalene block (ISB)
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%).
- PROCEDURE
-
Group B:will receive an ultrasound-guided infraspinatus-teres minor (ITM) interfacial plane block
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%).
Sponsors & Collaborators
-
Misr University for Science and Technology
lead OTHER
Principal Investigators
-
Mohammed Hany Kamal, Prof. of anesthesia and pain · Misr University for Science and Technolog
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-15
- Primary Completion
- 2026-01-20
- Completion
- 2026-01-31
Countries
- Egypt
Study Locations
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