Postoperative PainSISANCT07668648
Interscalene Brachial Plexus Block Versus Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery
A study testing Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block and Bupivacaine in people with Postoperative Pain and Shoulder Arthroscopy, run by Ferit Yetik at 1 site in Turkey (Türkiye).
Trial summary
Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Shoulder Arthroscopy
- What is being tested?
- Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2026to 15 Dec 2026
- 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
- ASA physical status I, II, or III
- Scheduled for elective arthroscopic shoulder surgery under general anesthesia
- Provision of written informed consent
Who cannot join
- Refusal to participate in the study
- Coagulopathy
- Current anticoagulant therapy
- Infection at the block site
- Previous surgery involving the planned block site
- Known allergy or history of toxicity to local anesthetics
Show all 14Show fewer
- Hepatic failure
- Renal failure
- Uncontrolled diabetes mellitus
- Cognitive impairment or mental disability preventing reliable assessment
- Chronic opioid use or ongoing chronic pain treatment
- Pregnancy, suspected pregnancy, or breastfeeding
- Chronic pulmonary disease (e.g., COPD or asthma)
- Failed block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Nilüfer
Mürsel Ekinci, MD, 05067137596, drmurselekinci@gmail.com
Onur Güneş, MD, +905319418938, onurguness96@gmail.com
About this study
Official title: Comparison of Interscalene Brachial Plexus Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Controlled Trial
Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. The serratus posterior superior intercostal plane (SPSIP) block is a recently described fascial plane block that may provide effective analgesia while avoiding some of the limitations of ISB.
This prospective, randomized, double-blind controlled trial aims to compare the analgesic efficacy of ISB and SPSIP block in patients undergoing elective arthroscopic shoulder surgery under general anesthesia. The primary outcome is total postoperative opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, quality of recovery, time to first rescue analgesia, rescue analgesic requirements, intraoperative opioid consumption, sensory block distribution, motor block characteristics, and block-related complications.
Read the detailed description
Postoperative pain following arthroscopic shoulder surgery can adversely affect patient comfort, early mobilization, rehabilitation, and overall recovery. Although the interscalene brachial plexus block is considered the reference regional anesthesia technique for shoulder surgery, its use may be limited by adverse effects such as hemidiaphragmatic paresis, phrenic nerve involvement, and upper extremity motor weakness.
The serratus posterior superior intercostal plane block is a novel ultrasound-guided fascial plane block targeting the posterior thoracic region. Preliminary evidence suggests that it may provide analgesia extending to the shoulder area through spread to cervical and upper thoracic dermatomes. However, comparative clinical evidence between SPSIP block and ISB for arthroscopic shoulder surgery remains limited.
In this prospective, randomized, double-blind controlled trial, eligible adult patients scheduled for elective arthroscopic shoulder surgery under general anesthesia will be randomly assigned to receive either an ultrasound-guided ISB or SPSIP block. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
The primary endpoint will be total opioid consumption during the first 24 postoperative hours. Secondary endpoints will include postoperative Numeric Rating Scale (NRS) pain scores at predefined time points, quality of recovery assessed with the QoR-15 questionnaire, intraoperative opioid consumption, time to first rescue analgesic requirement, total rescue analgesic consumption, sensory block distribution, motor block assessment, and block-related adverse events.
The study aims to determine whether SPSIP block can provide postoperative analgesia comparable to ISB while potentially reducing complications associated with brachial plexus blockade.
- Conditions
- Postoperative Pain, Shoulder Arthroscopy
- Being tested
- Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block, Bupivacaine
- Keywords
- Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene Brachial Plexus BlockProcedure or surgery
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Ultrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery.
BupivacaineDrug
Bupivacaine administered for ultrasound-guided regional anesthesia block.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Brachial Plexus Block Group | Experimental | Participants receive an ultrasound-guided interscalene brachial plexus block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. Receives: Procedure: Interscalene Brachial Plexus Block; Drug: Bupivacaine |
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption During the First 24 Postoperative Hours
Comparison of total postoperative opioid consumption between the interscalene brachial plexus block group and the serratus posterior superior intercostal plane block group during the first 24 hours after surgery.
Measured: 24 hours after surgery
Secondary outcomes (6)
Postoperative Pain Scores
Numeric Rating Scale (NRS) pain scores at rest and during movement, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery (QoR-15)
Quality of Recovery-15 (QoR-15) score assessed 24 hours after surgery. Scores range from 0 to 150, with higher scores indicating better postoperative recovery and patient satisfaction.
Measured: 24 hours after surgery
Intraoperative Remifentanil Consumption
Total remifentanil consumption during surgery.
Measured: During surgery
Time to First Rescue Analgesic Requirement
Time elapsed from the end of surgery to the first rescue analgesic administration.
Measured: First 24 postoperative hours
Rescue Analgesic Consumption
Total rescue analgesic consumption during the postoperative period.
Measured: First 24 postoperative hours
Block-Related and Opioid-Related Complications
Incidence of adverse events related to regional anesthesia techniques and opioid administration.
Measured: First 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start25 Jun 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 randomly assigned in a 1:1 ratio to receive either an ultrasound-guided interscalene brachial plexus block or a serratus posterior superior intercostal plane block before arthroscopic shoulder surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferit Yetik
- Sponsor type
- Other government
- Collaborators
- Bursa Sehir Hastanesi
- Responsible party
- Sponsor-investigator, Ferit Yetik, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mürsel Ekinci, Principal investigator, University of Health Sciences, Bursa Faculty of Medicine, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668648
- Sponsor's protocol ID
- 26-AKD-92
- Other IDs
- 26-AKD-92
- Acronym
- SISA
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Interscalene Brachial Plexus Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07668648
- Acronym / sponsor ID
- SISA / 26-AKD-92
- Conditions
- Postoperative Pain, Shoulder Arthroscopy
- Keywords
- Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Ultrasound-Guided Nerve Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ferit YetikOther government
- Collaborators
- Bursa Sehir Hastanesi
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthroscopic shoulder surgery is associated with moderate to severe postoperative pain that may delay recovery and rehabilitation. Interscalene brachial plexus block (ISB) is widely used for postoperative analgesia in shoulder surgery; however, it may be associated with complications such as phrenic nerve paralysis. The serratus posterior superior intercostal plane (SPSIP) block is a recently described fascial plane block that may provide effective analgesia while avoiding some of the limitations of ISB.
This prospective, randomized, double-blind controlled trial aims to compare the analgesic efficacy of ISB and SPSIP block in patients undergoing elective arthroscopic shoulder surgery under general anesthesia. The primary outcome is total postoperative opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, quality of recovery, time to first rescue analgesia, rescue analgesic requirements, intraoperative opioid consumption, sensory block distribution, motor block characteristics, and block-related complications.
Detailed description
Postoperative pain following arthroscopic shoulder surgery can adversely affect patient comfort, early mobilization, rehabilitation, and overall recovery. Although the interscalene brachial plexus block is considered the reference regional anesthesia technique for shoulder surgery, its use may be limited by adverse effects such as hemidiaphragmatic paresis, phrenic nerve involvement, and upper extremity motor weakness.
The serratus posterior superior intercostal plane block is a novel ultrasound-guided fascial plane block targeting the posterior thoracic region. Preliminary evidence suggests that it may provide analgesia extending to the shoulder area through spread to cervical and upper thoracic dermatomes. However, comparative clinical evidence between SPSIP block and ISB for arthroscopic shoulder surgery remains limited.
In this prospective, randomized, double-blind controlled trial, eligible adult patients scheduled for elective arthroscopic shoulder surgery under general anesthesia will be randomly assigned to receive either an ultrasound-guided ISB or SPSIP block. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
The primary endpoint will be total opioid consumption during the first 24 postoperative hours. Secondary endpoints will include postoperative Numeric Rating Scale (NRS) pain scores at predefined time points, quality of recovery assessed with the QoR-15 questionnaire, intraoperative opioid consumption, time to first rescue analgesic requirement, total rescue analgesic consumption, sensory block distribution, motor block assessment, and block-related adverse events.
The study aims to determine whether SPSIP block can provide postoperative analgesia comparable to ISB while potentially reducing complications associated with brachial plexus blockade.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided interscalene brachial plexus block or a serratus posterior superior intercostal plane block before arthroscopic shoulder surgery.
| Arm | Type | Receives |
|---|---|---|
| Interscalene Brachial Plexus Block Group | Experimental | Procedure: Interscalene Brachial Plexus Block, Drug: BupivacaineParticipants receive an ultrasound-guided interscalene brachial plexus block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. |
| Serratus Posterior Superior Intercostal Plane Block Group | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane Block, Drug: BupivacaineParticipants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia for postoperative analgesia during arthroscopic shoulder surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- ASA physical status I, II, or III
- Scheduled for elective arthroscopic shoulder surgery under general anesthesia
- Provision of written informed consent
Key exclusion criteria (14 listed)
- Refusal to participate in the study
- Coagulopathy
- Current anticoagulant therapy
- Infection at the block site
- Previous surgery involving the planned block site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene Brachial Plexus BlockUltrasound-guided interscalene brachial plexus block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery. | Procedure or surgery | Interscalene Brachial Plexus Block Group |
| Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided serratus posterior superior intercostal plane block performed before induction of general anesthesia for postoperative analgesia in arthroscopic shoulder surgery. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| BupivacaineBupivacaine administered for ultrasound-guided regional anesthesia block. | Drug | Interscalene Brachial Plexus Block Group, Serratus Posterior Superior Intercostal Plane Block Group |
Primary outcome
Total Opioid Consumption During the First 24 Postoperative Hours
Time frame: 24 hours after surgery
Comparison of total postoperative opioid consumption between the interscalene brachial plexus block group and the serratus posterior superior intercostal plane block group during the first 24 hours after surgery.
6 secondary outcomes
Postoperative Pain Scores
Time frame: 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery (QoR-15)
Time frame: 24 hours after surgery
Intraoperative Remifentanil Consumption
Time frame: During surgery
Time to First Rescue Analgesic Requirement
Time frame: First 24 postoperative hours
Rescue Analgesic Consumption
Time frame: First 24 postoperative hours
Block-Related and Opioid-Related Complications
Time frame: First 24 postoperative hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mürsel Ekinci principal investigator
University of Health Sciences, Bursa Faculty of Medicine, Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene Brachial Plexus Block, Serratus Posterior Superior Intercostal Plane Block and Bupivacaine in people with Postoperative Pain and Shoulder Arthroscopy, run by Ferit Yetik 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 4 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: looking for participants now, as of the sponsor's last update on 29 Jun 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 Mürsel Ekinci, MD (+905067137596, drmurselekinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Consumption During the First 24 Postoperative Hours (time frame: 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 29 Jun 2026.