Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy

NCT07852754 | Not Yet Recruiting

• 1 other identifier: FSMTRH-SSPB-PEC1-2026-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Hemidiaphragmatic Paresis

Keywords

Shoulder Arthroscopy; Postoperative Analgesia; Suprascapular Nerve Block; PECS I Block; Interscalene Brachial Plexus Block; Hemidiaphragmatic Paresis; Diaphragmatic Excursion; Ultrasound-Guided Regional Anesthesia; Tramadol Consumption; Non-Inferiority Trial

Outcome Measures

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.

  From the end of surgery to 24 hours after surgery

Secondary Outcomes (9)

• Change in Ipsilateral Hemidiaphragmatic Excursion

  Preoperative baseline and 30 minutes after block administration in the post-anesthesia care unit

• Incidence of Hemidiaphragmatic Paresis

  30 minutes after block administration in the post-anesthesia care unit

• Postoperative Pain Intensity at Rest

  At 1, 6, 12, and 24 hours after surgery

• Pain Intensity During the First Supervised Shoulder Exercise

  During the first supervised postoperative shoulder exercise, within 24 hours after surgery

• Quality of Recovery at 24 Hours

  24 hours after surgery

Study Arms (2)

Combined Suprascapular Nerve and PECS I Blocks

EXPERIMENTAL

At the end of surgery, while the participant is under general anesthesia, an ultrasound-guided suprascapular nerve block will be performed with 15 mL of 0.25% bupivacaine, followed by an ultrasound-guided PECS I block with 10 mL of 0.25% bupivacaine injected between the pectoralis major and pectoralis minor muscles. Participants will receive standardized general anesthesia and postoperative intravenous patient-controlled analgesia with tramadol.

Procedure: suprascapular nerve block; Procedure: PECS I Block

Interscalene Brachial Plexus Block

ACTIVE COMPARATOR

At 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. Participants will receive standardized general anesthesia and postoperative intravenous patient-controlled analgesia with tramadol.

Procedure: Interscalene Brachial Plexus Block

Interventions

suprascapular nerve block PROCEDURE

At 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.

Combined Suprascapular Nerve and PECS I Blocks

PECS I Block PROCEDURE

At 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.

Combined Suprascapular Nerve and PECS I Blocks

Interscalene Brachial Plexus Block PROCEDURE

At 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.

Interscalene Brachial Plexus Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to understand and use the study pain-rating scales

You may not qualify if:

• 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
• Severe cardiopulmonary disease, defined as New York Heart Association functional class III or IV or a forced expiratory volume in one second below 50% of the predicted value
• Contralateral phrenic nerve paralysis or a single functional lung
• Chronic opioid use, defined as daily opioid use for more than 3 months
• Regular analgesic use for chronic shoulder pain
• History of neuromuscular disease
• Pregnancy or breastfeeding
• Psychiatric or cognitive condition preventing reliable completion of the study assessments
• Revision shoulder surgery
• Preexisting neurological deficit in the ipsilateral upper extremity
• Refusal to participate

Sponsors & Collaborators

• Cansu Ofluoğlu: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

cansu ofluoglu, MD

CONTACT

+905358640564; cansuakin.iu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their assigned intervention because the regional blocks will be performed at the end of surgery while they are under general anesthesia. The anesthesiologist performing the block will not be masked to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Model Details: Participants will be randomized in a 1:1 ratio to receive either a combined ultrasound-guided suprascapular nerve block and PECS I block or an ultrasound-guided interscalene brachial plexus block. Both interventions will be performed at the end of surgery while participants are under general anesthesia. Participants will receive the same standardized postoperative analgesic regimen and will be followed for 24 hours after surgery.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

TU (1)