- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259785
SPSIPB vs CCB in Arthroscopic Shoulder Surgeries
June 2, 2026 updated by: Oguz Gundogdu, Cumhuriyet University
Comparison of the Effects of Serratus Posterior Superior Intercostal Plane Block Versus Costoclavicular Brachial Plexus Block on Postoperative Pain and Hemidiaphragmatic Paralysis in Arthroscopic Shoulder Surgeries
The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing arthroscopic shoulder surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients were divided into two randomized groups: Group 1 (SPSIPB group, n=15) and Group 2 (CCBPB group, n=15).
All patients will receive the same standard general anesthesia per hospital protocol.
All blocks will be applied with the same ultrasonography and block equipment, and by the same physician.
Before the anesthesia induction, ipsilateral diaphragmatic excursion will be measured via Ultrasonography (USG).
After the anesthesia induction, patients in Group 1 will receive Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with 30 mL of 0.25% bupivacaine.
Patients in Group 2 will receive Costoclavicular Brachial Plexus Block (CCBPB) with 15 mL of 0.25% bupivacaine.
All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure.
After 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring), ipsilateral diaphragmatic excursion will be assessed again.
Pre- and postblock excursion differences will be recorded.
Routine analgesic procedure consisting of 3x1gr Paracetamol IV and 2x50mg Dexketoprofen IV will be followed postoperatively for 24 hours.
Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery.
Quality of Recovery-15 Patient Survey will be done both preoperatively for a baseline score, and postoperatively at 24th hour to assess the quality of recovery from the patients' view.
Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University
-
-
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:
- Adult patients older than 18 years of age who underwent unilateral elective arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) score I-II-III according to the ASA risk classification.
Exclusion Criteria:
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SPSIPB
SPSIPB will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in lateral position.The ultrasound probe was placed 2-3 cm medial to the scapular spine to visualize the trapezius, rhomboid major, and serratus posterior superior muscles.
At the level of the 2nd-3rd ribs, a needle was advanced into the plane between the serratus posterior superior muscle and the ribs.
After confirming the placement of the needle tip with negative aspiration, 30 mL of 0.25% bupivacaine was injected.
The block was performed unilaterally, targeting the shoulder undergoing surgery.
|
30 mL of 0.25% bupivacaine
|
|
Active Comparator: CCBPB
CCBPB will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position.
For CCBPB, a high frequency linear transducer of the USG is placed in the medial infraclavicular fossa parallel and next to the clavicle to identify the axillary artery.
The transducer is then tilted cephalad to image the brachial plexus and the artery in a perpendicular orientation between the subclavius muscle and the serratus anterior.
The needle is advanced in-plane in a lateral-to-medial direction, adjusting the angle to reach the space in between the three cords.
15 mL of 0.25% bupivacaine is administered.
|
15 mL of 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS) Scores
Time Frame: Postoperative 24 hours
|
Numerical rating scale is used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
|
Postoperative 24 hours
|
|
Diaphragmatic Excursion Difference
Time Frame: Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)
|
Ipsilateral diaphragmatic excursions will be measured both preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring).
A diaphragmatic excursion change of up to 25% indicates no nerve involvement, a change between 25%-75% indicates partial involvement, and a change exceeding 75% indicates complete involvement of the phrenic nerve.
|
Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery-15 Patient Survey (QoR-15)
Time Frame: Preoperatively and Postoperatively at 24th hour
|
The widespread use of minimally invasive interventions to reduce postoperative mortality and morbidity, combined with the implementation of Enhanced Recovery After Surgery (ERAS) protocols, has heightened overall interest in the postoperative recovery period and the importance of outcome evaluation.
To address the emerging needs in this field, new tools prioritizing patient satisfaction have been developed alongside traditional scales that measure classical parameters.
The Quality of Recovery-15 Patient Survey (QoR-15) stands out as one of the most up-to-date and reliable examples among these tools.
The survey is done both preoperatively to record patients' baseline score, and postoperatively at 24th hour.
Higher scores mean better quality of recovery after surgery.
Mininum and maximum scores can be '0 (zero)' and '150 (one hundred and fifty)' respectively.
|
Preoperatively and Postoperatively at 24th hour
|
|
Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total opioid need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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 (Actual)
November 1, 2025
Primary Completion (Actual)
May 25, 2026
Study Completion (Actual)
June 2, 2026
Study Registration Dates
First Submitted
November 21, 2025
First Submitted That Met QC Criteria
November 21, 2025
First Posted (Actual)
December 2, 2025
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 2, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-10/12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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