- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06844630
Interscalene vs Infraspinatus-teres Minor (ITM) Interfascial Block in Shoulder Surgery
Comparison of Postoperative Analgesic Efficacy Between the Interscalene Block and Infraspinatus-Teres Minor Interfascial Blocks in Patients Undergoing Arthroscopic Shoulder Surgery
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalene brachial plexus block is one of the most preferred techniques among these.
Due to the phrenic nerve paralysis frequently seen in interscalene block, alternative diaphragm-sparing block techniques have emerged over time. One of these is the Infraspinatus teres minor interfascial block. Infraspinatus teres minor interfascial block can block both the suprascapular nerve and the axillary nerve, which are effective in the innervation of the shoulder, with a single-point injection.
The main aim of our study was to show that there is no difference between interscalene block and infraspinatus-teres-minor interfascial block in terms of their effects on postoperative analgesia in patients undergoing arthroscopic shoulder surgery.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey (Türkiye), 55090
- Samsun University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Exclusion Criteria:
- history of bleeding diathesis
- receiving anticoagulant treatment
- infection of the skin at the site of the needle puncture
- pregnancy or lactation
- patients who do not accept the procedure
- Allergy to local anesthetics
- Chronic pain syndromes requiring opioid intake
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interscalene Block
Patients randomized to receive interscalene block
|
Before surgery, patients will receive a unilateral interscalene block under ultrasound guidance.
|
|
Experimental: Infraspinatus-teres minor (ITM) interfascial block
Patients randomized to receive Infraspinatus-teres minor (ITM) interfascial block
|
Before surgery, patients will receive a unilateral infraspinatus-teres minor interfascial block under ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24 hours opioid consumption
Time Frame: Time Frame: up to 24 hours
|
morphine consumptions via patient controlled analgesia device for both group will be recorded
|
Time Frame: up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory and Motor block score
Time Frame: 30 minutes post injection
|
Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite.
Block level will be evaluated between 0-8 points score
|
30 minutes post injection
|
|
Numeric rating scale for postoperative pain intensity
Time Frame: up to 24 hours (Will be evaluated at 1, 3, 6, 12, 18, 24 hours)
|
Evaluated with a Numerical rating scale (NRS) from 0 to 10. (0=no pain; 10=worst imaginable pain)
|
up to 24 hours (Will be evaluated at 1, 3, 6, 12, 18, 24 hours)
|
|
Quality of Recovery - 15 score
Time Frame: Postoperative 24th hour
|
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool.
Each question is scored between 0 and 10.
The survey result varies between 0-150 points based on the answers given by the patients.
Higher scores indicate better recovery.
|
Postoperative 24th hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.
- Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738.
- Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SamsunOm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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