- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06660875
Comparison of Postoperative Analgesic Efficacy of SPSIPB and Combination of IBPB and SCPB
Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superıor Intercostal Plane Block and Combination of Interscalene Brachial Plexus Block and Superfisial Plexus Block in Shoulder Arthroscopies
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Musa Zengin, Associate Professor
- Phone Number: 00905307716235
- Email: musazengin@gmail.com
Study Contact Backup
- Name: MÜRÜVVET TAŞKIR TURAN, MD
- Phone Number: 00905065536934
- Email: taskirmuruvvet@gmail.com
Study Locations
-
-
Ankara
-
Yenimahalle, Ankara, Turkey, 06170
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Musa Zengin, Associate Professor
- Phone Number: 00905307716235
- Email: musazengin@gmail.com
-
Contact:
- MÜRÜVVET TAŞKIR TURAN, MD
- Phone Number: 00905065536934
- Email: taskirmuruvvet@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective shoulder arthroscopy surgery
Exclusion Criteria:
- Under 18 and over 65
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- BMI under 18 kg/m2 and over 30 kg/m2
- Patient refusing the procedure
- Patients who have previously undergone shoulder surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo shoulder surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Serratus posterior superior intercostal plane block
With the patient in the prone position the skin is disinfected .Linear USG probe is placed on the spine of the scapula using an in-plane technique and moved medially.
The 3rd rib is identified just on the medial scapular border.
After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from top to bottom) under USG guidance, a 22-G X 80-mm block needle is directed caudally and advanced until it contacted the rib.
To confirm and obtain a plane between the serratus posterior superior and intercostal muscles, hydrodissection is performed using 2 ml of isotonic solution.
After the needle site is confirmed, 30 ml of 0.25% bupivacaine is injected ; the local anesthetic spread is confirmed by USG.
|
Serratus posterior superior intercostal plane block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.
|
|
Active Comparator: Interscalene brachial plexus block and superficial cervical plexus block
İBPB:While the patient is in the supine position, the ultrasound probe is placed on the cricoid cartilage and moved laterally to visualize the trachea, thyroid, carotid artery, internal jugular vein, and sternocleidomastoid muscle. The brachial plexus is identified by directing it posteriorly and laterally between the anterior and middle scalene muscles. After entering between the roots using the in-plane technique and confirming the location with a 2 ml isotonic sodium injection, 20 ml of 0.25% bupivacaine is injected. SCPB:While the patient is in the supine position, the ultrasound probe is placed at the midpoint of the sternocleidomastoid (SCM) muscle. The cervical plexus is visualized deep to the posterior border of the SCM muscle. The needle is inserted deep to the SCM, directed towards the levator scapula. After confirming the location with a 2 ml isotonic sodium injection, 10 ml of 0.25% bupivacaine is injected. |
İnterscalene brachial plexus block and superficial cervical plexus block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative remifentanil consumption
Time Frame: During The intraoperatif period
|
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
|
During The intraoperatif period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: First 24 hours after surgery
|
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst pain).
Pain assessment will be done at the 1st, 2nd, 4th, 12th, and 24th hours after surgery
|
First 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- AEŞH-BADEK-1003-2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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