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Postoperative PainNCT07852754

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

A study testing suprascapular nerve block, PECS I Block and Interscalene Brachial Plexus Block in people with Postoperative Pain and Hemidiaphragmatic Paresis, run by Cansu Ofluoğlu at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postoperative Pain, Hemidiaphragmatic Paresis
What is being tested?
suprascapular nerve block, PECS I Block and Interscalene Brachial Plexus Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2026to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

cansu ofluoglu, MD contact

+905358640564

cansuakin.iu@gmail.com

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Training and Research Hospital

    Istanbul, 34000

    cansu ofluoglu, MD, +905358640564, cansuakin.iu@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Analgesic Efficacy and Hemidiaphragmatic Paresis With Combined Suprascapular Nerve Block and PECS I Block Versus Interscalene Block in Arthroscopic Shoulder Surgery: A Randomized Non-Inferiority 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.

Read more

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.

Read the detailed description

Interscalene brachial plexus block provides effective analgesia after shoulder surgery but is associated with ipsilateral phrenic nerve blockade and hemidiaphragmatic dysfunction. These effects may limit its use, particularly in patients with reduced respiratory reserve. The combination of suprascapular nerve block and PECS I block may provide broader coverage of the sensory innervation of the shoulder while reducing the risk of phrenic nerve involvement.

This prospective, single-center, randomized, single-blind, parallel-group, active-controlled non-inferiority trial will include 80 adults aged 18 to 75 years with American Society of Anesthesiologists physical status I to III who are scheduled for elective arthroscopic shoulder surgery. Participants will be randomly allocated in a 1:1 ratio to the combined-block group or the interscalene-block group.

All participants will receive standardized general anesthesia. At the end of surgery and before emergence from anesthesia, participants in the combined-block group will receive an ultrasound-guided suprascapular nerve block with 15 mL of 0.25% bupivacaine and an ultrasound-guided PECS I block with 10 mL of 0.25% bupivacaine. Participants in the interscalene-block group will receive an ultrasound-guided interscalene brachial plexus block with 15 mL of 0.5% bupivacaine.

Postoperative analgesia will be standardized in both groups using intravenous patient-controlled analgesia with tramadol. Pain intensity will be assessed using the 0-to-10 Numeric Rating Scale at 1, 6, 12, and 24 hours after surgery and during the first supervised postoperative exercise. Rescue analgesia with 50 mg of intravenous tramadol will be administered when the Numeric Rating Scale score is 4 or higher.

The primary objective is to determine whether the combined suprascapular nerve and PECS I blocks are non-inferior to the interscalene block with respect to cumulative tramadol consumption during the first 24 postoperative hours. The prespecified non-inferiority margin is 25% of the reference mean tramadol consumption in the interscalene-block group.

Hemidiaphragmatic excursion on the operated side will be measured using M-mode ultrasonography before surgery and 30 minutes after block administration in the post-anesthesia care unit. Additional outcomes will include postoperative pain scores, Quality of Recovery-15 score at 24 hours, time to first rescue analgesic administration, postoperative nausea and vomiting, antiemetic consumption, and block-related adverse events, including Horner syndrome, hoarseness, paresthesia, hematoma, and local anesthetic systemic toxicity.

Being tested
suprascapular nerve block, PECS I Block, Interscalene Brachial Plexus Block
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
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • suprascapular nerve blockProcedure or surgery

    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.

  • PECS I BlockProcedure or surgery

    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.

  • Interscalene Brachial Plexus BlockProcedure or surgery

    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.

Study groups in NCT07852754
Study groupRoleWhat they receive
Combined Suprascapular Nerve and PECS I BlocksExperimentalAt 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.
Receives: Procedure: suprascapular nerve block; Procedure: PECS I Block
Interscalene Brachial Plexus BlockActive comparatorAt 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.
Receives: Procedure: Interscalene Brachial Plexus Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From the end of surgery to 24 hours after surgery

Secondary outcomes (9)
  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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Quality of Recovery at 24 Hours

    Postoperative recovery will be evaluated using the 15-item Quality of Recovery questionnaire. The total Quality of Recovery-15 score ranges from 0 to 150, with higher scores indicating better overall postoperative recovery.

    Measured: 24 hours after surgery

  6. Time to First Rescue Analgesic Administration

    The elapsed time from emergence from general anesthesia to the first administration of rescue analgesia will be recorded in minutes. Rescue analgesia will consist of 50 mg of intravenous tramadol administered when the Numeric Rating Scale pain score is 4 or higher. Participants who do not require rescue analgesia will be censored at 24 hours.

    Measured: From emergence from anesthesia to 24 hours after surgery

  7. Incidence of Postoperative Nausea and Vomiting

    The number and percentage of participants experiencing at least one episode of nausea, vomiting, or both will be recorded. Each participant will be counted once for the overall incidence, regardless of the number of episodes.

    Measured: During the first 24 hours after surgery

  8. Rescue Antiemetic Requirement

    The number and percentage of participants who receive at least one dose of rescue antiemetic medication will be recorded. The number of rescue antiemetic doses administered to each participant will also be documented.

    Measured: During the first 24 hours after surgery

  9. Incidence of Block-Related Adverse Events

    The number and percentage of participants experiencing block-related adverse events will be recorded. Prespecified events include Horner syndrome, hoarseness, paresthesia, injection-site hematoma, and local anesthetic systemic toxicity. Each adverse event will also be recorded separately.

    Measured: From block administration to 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852754
Sponsor's protocol ID
FSMTRH-SSPB-PEC1-2026-01
Status last verified
Sep 2026
First submitted
25 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing suprascapular nerve block, PECS I Block and Interscalene Brachial Plexus Block in people with Postoperative Pain and Hemidiaphragmatic Paresis, run by Cansu Ofluoğlu at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact cansu ofluoglu, MD (+905358640564, cansuakin.iu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Tramadol Consumption During the First 24 Postoperative Hours (time frame: From the end of surgery to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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