Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCansu Ofluoğlu
About this trial
Shoulder arthroscopy can cause moderate to severe pain after surgery. An interscalene block is commonly used to reduce this pain, but it may temporarily weaken movement of the diaphragm on the treated side.
This study will compare an interscalene block with a combination of suprascapular nerve block and PECS I block in adults undergoing elective shoulder arthroscopy. The researchers want to determine whether the combined blocks provide pain relief that is not meaningfully worse than the interscalene block while causing less impairment of diaphragm movement.
A total of 80 participants will be randomly assigned to one of two groups. All participants will receive general anesthesia. At the end of surgery, while participants are still under anesthesia, one group will receive the combined suprascapular nerve and PECS I blocks, and the other group will receive an interscalene block. Both groups will use the same intravenous patient-controlled pain pump containing tramadol after surgery.
The main outcome will be the total amount of tramadol used during the first 24 hours after surgery. The study will also assess pain scores, diaphragm movement measured by ultrasound, quality of recovery, time until additional pain medicine is first needed, nausea and vomiting, anti-nausea medicine use, and block-related side effects during the first 24 hours.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
American Society of Anesthesiologists physical status I to III
Scheduled for elective arthroscopic shoulder surgery, including rotator cuff repair, superior labrum anterior-to-posterior lesion repair, Bankart lesion repair, subacromial decompression, or acromioplasty
Able to provide written informed consent
Disqualifiers
Known allergy or contraindication to local anesthetics
Coagulopathy, defined as an international normalized ratio greater than 1.5 or a platelet count below 80,000/µL
Current anticoagulant or antiplatelet treatment
Active infection or skin lesion at the planned injection site
Trial design
Design model
Parallel
Treatments tested in this trial
suprascapular nerve block
Procedure/SurgeryAt the end of surgery, while the participant is under general anesthesia, an ultrasound-guided suprascapular nerve block will be performed using 15 mL of 0.25% bupivacaine injected into the suprascapular fascial plane through a medial-to-coracoid approach. This intervention will be administered together with the PECS I block in the experimental arm.
PECS I Block
Procedure/SurgeryAt the end of surgery, while the participant is under general anesthesia, an ultrasound-guided PECS I block will be performed using 10 mL of 0.25% bupivacaine injected into the fascial plane between the pectoralis major and pectoralis minor muscles. This intervention will be administered together with the suprascapular nerve block in the experimental arm.
Interscalene Brachial Plexus Block
Procedure/SurgeryAt the end of surgery, while the participant is under general anesthesia, an ultrasound-guided interscalene brachial plexus block will be performed at the C5-C6 nerve root level using 15 mL of 0.5% bupivacaine injected between the anterior and middle scalene muscles.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Combined Suprascapular Nerve and PECS I BlocksExperimental treatment 2 interventions
Group B: Interscalene Brachial Plexus BlockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
The total dose of intravenous tramadol administered to each participant through patient-controlled analgesia and as rescue analgesia will be calculated from the patient-controlled analgesia record and medication chart and reported in milligrams. Higher values indicate greater postoperative analgesic requirement. Cumulative tramadol consumption will be compared between the combined suprascapular nerve and PECS I block group and the interscalene block group to assess non-inferiority of postoperative analgesia.
Time frame
From the end of surgery to 24 hours after surgerySecondary outcomes
1
Change in Ipsilateral Hemidiaphragmatic Excursion
Hemidiaphragmatic excursion on the operated side will be measured in centimeters using M-mode ultrasonography. The mean of three respiratory cycles will be recorded at each assessment. The absolute change and percentage reduction from the preoperative baseline value will be calculated. A greater reduction indicates greater diaphragmatic impairment.
Time frame
Preoperative baseline and 30 minutes after block administration in the post-anesthesia care unit2
Incidence of Hemidiaphragmatic Paresis
Hemidiaphragmatic function will be classified according to the percentage reduction in excursion from the preoperative baseline value. A reduction of less than 25% will indicate no paresis, a reduction of 25% to 75% will indicate partial paresis, and a reduction greater than 75% or paradoxical movement will indicate complete paresis. The number and percentage of participants with partial or complete paresis will be reported.
Time frame
30 minutes after block administration in the post-anesthesia care unit3
Postoperative Pain Intensity at Rest
Pain intensity at rest will be assessed using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded separately at each specified postoperative time point. Lower scores indicate less pain.
Time frame
At 1, 6, 12, and 24 hours after surgery4
Pain Intensity During the First Supervised Shoulder Exercise
Pain during the first postoperative shoulder exercise performed under orthopedic supervision will be assessed using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less movement-related pain.
Time frame
During the first supervised postoperative shoulder exercise, within 24 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Cansu Ofluoğlu
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Sponsor institution
Source ClinicalTrials.gov
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