- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07670780
Interscalene Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Shoulder Arthroscopy
June 29, 2026 updated by: Recep Aksu, TC Erciyes University
Comparison of the Effects of Interscalene Block and Infraspinatus-Teres Minor Interfascial Plane Block on Postoperative Analgesia and Diaphragmatic Function in Patients Undergoing Shoulder Arthroscopy.
This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy.
A total of 120 patients will be enrolled and allocated into three groups.
Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups.
The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.
Study Overview
Status
Not yet recruiting
Detailed Description
Shoulder arthroscopy is associated with significant postoperative pain.
Interscalene block is widely used for analgesia but may impair diaphragmatic function because of phrenic nerve involvement.
The infraspinatus-teres minor interfascial plane block has been proposed as an alternative regional anesthesia technique that may provide adequate analgesia while preserving diaphragmatic function.
This randomized controlled trial will include 120 adult patients undergoing elective shoulder arthroscopy.
Participants will be randomized into three groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control.
Pain scores, opioid consumption, time to first rescue analgesia, diaphragmatic excursion measured by ultrasound, and block-related complications will be recorded and analyzed.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective shoulder arthroscopy
- No known allergy to study medications
- No psychiatric disorder
- No opioid dependence
- Ability to use patient-controlled analgesia (PCA) and complete VAS assessments
- No contraindication to peripheral nerve blocks
- Written informed consent obtained
Exclusion Criteria:
- Refusal to participate
- Uncontrolled hypertension
- Chronic pain or ongoing analgesic treatment
- Significant cardiac disease (coronary artery disease, arrhythmia, heart failure)
- Diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Interscalene Block Group
Patients receive ultrasound-guided interscalene brachial plexus block for postoperative analgesia following shoulder surgery.
|
Ultrasound-guided interscalene brachial plexus block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy.
The block is administered using ultrasound guidance according to institutional practice.
|
|
Experimental: Infraspinatus-Teres Minor Interfascial Plane Block Group
Patients receive ultrasound-guided infraspinatus-teres minor interfascial plane block for postoperative analgesia after shoulder surgery.
|
Ultrasound-guided infraspinatus-teres minor interfascial plane block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy.
The block is administered using ultrasound guidance according to institutional practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic Excursion
Time Frame: 24 hours after surgery
|
Comparison of postoperative diaphragmatic excursion measured by ultrasonography between study groups.
|
24 hours after surgery
|
|
Postoperative Pain Intensity
Time Frame: 0, 2,4, 6, 12, and 24 hours after surgery
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) , ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
higher scores indicate greater pain intensity.
compared between study groups.
|
0, 2,4, 6, 12, and 24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 22, 2026
Primary Completion (Estimated)
June 22, 2028
Study Completion (Estimated)
August 28, 2028
Study Registration Dates
First Submitted
June 22, 2026
First Submitted That Met QC Criteria
June 22, 2026
First Posted (Actual)
June 26, 2026
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-AKD-187
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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