Postoperative PainESP-SPSIPNCT07906392
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
A study testing High Thoracic Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Pain, run by Ferit Yetik at 1 site in Turkey (Türkiye).
Trial summary
This study will compare two regional anesthesia techniques for pain relief after arthroscopic shoulder surgery: high thoracic erector spinae plane (ESP) block and serratus posterior superior intercostal plane (SPSIP) block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- High Thoracic Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Injection or infusion, 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
- 15 Nov 2026to 15 Mar 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
- Scheduled for elective arthroscopic shoulder surgery under general anesthesia.
- Provision of informed consent.
- Age between 18 and 75 years.
- American Society of Anesthesiologists (ASA) physical status I-III. -
Who cannot join
- History of bleeding diathesis or current anticoagulant therapy.
- Known allergy to local anesthetics or opioid medications.
- Infection at the planned block injection site.
- Suspected pregnancy, pregnancy, or breastfeeding.
- Refusal to participate.
- Uncontrolled diabetes mellitus.
Show all 9Show fewer
- Intellectual disability.
- Regular opioid use for chronic pain management.
- Technical inability to successfully perform the assigned 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
Bursa City Hospital
Bursa, Nilüfer, 16100
Yusuf Alan, MD, +905396210977, dryusufalan@gmail.com
Yusuf Alan, MD
About this study
Official title: Omparison of the Effects of High Thoracic Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia in Shoulder Arthroscopy: A Prospective, Double-Blind, Randomized Controlled Trial
This study will compare two regional anesthesia techniques for pain relief after arthroscopic shoulder surgery: high thoracic erector spinae plane (ESP) block and serratus posterior superior intercostal plane (SPSIP) block. Both techniques involve injecting a local anesthetic into tissue layers in the upper back under ultrasound guidance.
The study will include 80 adults aged 18 to 75 years undergoing elective arthroscopic shoulder surgery at Bursa City Hospital. Participants will be randomly assigned to receive either an ESP block or an SPSIP block before general anesthesia. Participants and the clinician assessing postoperative outcomes will not know which block was assigned.
Read more
All participants will receive a standardized pain management regimen, including a patient-controlled analgesia (PCA) pump that delivers tramadol when they press a button. Additional pain relief will be provided when needed.
The main aim is to compare the total amount of tramadol delivered by the PCA pump during the first 24 hours after surgery. Other assessments will include pain at rest and during movement, quality of recovery at 24 hours, additional pain medication requirements, remifentanil use during surgery, and side effects or complications related to the blocks and opioid medications.
- Conditions
- Postoperative Pain
- Being tested
- High Thoracic Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Shoulder Arthroscopy, Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Postoperative Analgesia, Patient-Controlled Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Thoracic Erector Spinae Plane BlockProcedure or surgery
Also called ESP Block
Before general anesthesia, an ultrasound-guided block will be performed at the T2 level on the surgical side with the participant in the sitting position. A single injection of 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000 will be administered into the fascial plane between the erector spinae muscle and the transverse process.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Also called SPSIP Block
Before general anesthesia, an ultrasound-guided block will be performed on the surgical side with the participant in the sitting position and the hand placed on the opposite shoulder. The probe will be positioned sagittally medial to the scapula at the second and third ribs. Following hydrodissection with 2 mL of saline, a single injection of 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000 will be administered into the plane between the serratus posterior superior and intercostal muscles.
| Study group | Role | What they receive |
|---|---|---|
| High Thoracic ESP Block | Experimental | Participants will receive an ultrasound-guided high thoracic erector spinae plane (ESP) block at the T2 level on the surgical side before general anesthesia, using 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000. All participants will receive standardized general anesthesia and postoperative multimodal analgesia, including tramadol patient-controlled analgesia. Receives: Procedure: High Thoracic Erector Spinae Plane Block |
| SPSIP Block | Experimental | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block on the surgical side before general anesthesia, using 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000. All participants will receive standardized general anesthesia and postoperative multimodal analgesia, including tramadol patient-controlled analgesia. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total PCA Tramadol Consumption During the First 24 Hours After Surgery
The cumulative dose of tramadol delivered through the intravenous patient-controlled analgesia (PCA) pump during the first 24 postoperative hours will be recorded in milligrams and compared between the groups. Only tramadol actually delivered by the PCA pump will be included. Intraoperative tramadol and rescue meperidine will not be included in this outcome.
Measured: First 24 hours after surgery
Secondary outcomes (5)
Postoperative Pain at Rest
Pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be compared between the groups at each assessment time point.
Measured: At 0, 2, 4, 8, 16, and 24 hours after surgery
Postoperative Pain During Movement
Pain intensity during movement will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be compared between the groups at each assessment time point.
Measured: At 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. Total scores will be compared between the groups.
Measured: At 24 hours after surgery
Incidence of Block-Related Complications
The number and percentage of participants experiencing complications related to the regional block will be recorded and compared between the groups. The type of each complication will be documented.
Measured: From block administration through 24 hours after surgery
Incidence of Opioid-Related Adverse Effects
The number and percentage of participants experiencing opioid-related adverse effects, including nausea, vomiting, and pruritus, will be recorded and compared between the groups. Each adverse effect will be documented separately.
Measured: First 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.
- First posted30 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completion15 Mar 2027 (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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferit Yetik
- Sponsor type
- Other government
- Collaborators
- Bursa City Hospital
- Responsible party
- Sponsor-investigator, Ferit Yetik, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mürsel Ekinci, Principal investigator, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906392
- Sponsor's protocol ID
- 26-AKD-71
- Acronym
- ESP-SPSIP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omparison of the Effects of High Thoracic Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia in Shoulder Arthroscopy: A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07906392
- Acronym / sponsor ID
- ESP-SPSIP / 26-AKD-71
- Conditions
- Postoperative Pain
- Keywords
- Shoulder Arthroscopy, Erector Spinae Plane Block, Serratus Posterior Superior Intercostal Plane Block, Regional Anesthesia, Postoperative Analgesia, Patient-Controlled Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ferit YetikOther government
- Collaborators
- Bursa City Hospital
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 30 Oct 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.
This study will compare two regional anesthesia techniques for pain relief after arthroscopic shoulder surgery: high thoracic erector spinae plane (ESP) block and serratus posterior superior intercostal plane (SPSIP) block. Both techniques involve injecting a local anesthetic into tissue layers in the upper back under ultrasound guidance.
The study will include 80 adults aged 18 to 75 years undergoing elective arthroscopic shoulder surgery at Bursa City Hospital. Participants will be randomly assigned to receive either an ESP block or an SPSIP block before general anesthesia. Participants and the clinician assessing postoperative outcomes will not know which block was assigned.
All participants will receive a standardized pain management regimen, including a patient-controlled analgesia (PCA) pump that delivers tramadol when they press a button. Additional pain relief will be provided when needed.
The main aim is to compare the total amount of tramadol delivered by the PCA pump during the first 24 hours after surgery. Other assessments will include pain at rest and during movement, quality of recovery at 24 hours, additional pain medication requirements, remifentanil use during surgery, and side effects or complications related to the blocks and opioid medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Thoracic ESP Block | Experimental | Procedure: High Thoracic Erector Spinae Plane BlockParticipants will receive an ultrasound-guided high thoracic erector spinae plane (ESP) block at the T2 level on the surgical side before general anesthesia, using 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000. All participants will receive standardized general anesthesia and postoperative multimodal analgesia, including tramadol patient-controlled analgesia. |
| SPSIP Block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block on the surgical side before general anesthesia, using 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000. All participants will receive standardized general anesthesia and postoperative multimodal analgesia, including tramadol patient-controlled analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for elective arthroscopic shoulder surgery under general anesthesia.
- Provision of informed consent.
- Age between 18 and 75 years.
- American Society of Anesthesiologists (ASA) physical status I-III. -
Key exclusion criteria (9 listed)
- History of bleeding diathesis or current anticoagulant therapy.
- Known allergy to local anesthetics or opioid medications.
- Infection at the planned block injection site.
- Suspected pregnancy, pregnancy, or breastfeeding.
- Refusal to participate.
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 |
|---|---|---|
| High Thoracic Erector Spinae Plane BlockAlso: ESP BlockBefore general anesthesia, an ultrasound-guided block will be performed at the T2 level on the surgical side with the participant in the sitting position. A single injection of 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000 will be administered into the fascial plane between the erector spinae muscle and the transverse process. | Procedure or surgery | High Thoracic ESP Block |
| Serratus Posterior Superior Intercostal Plane BlockAlso: SPSIP BlockBefore general anesthesia, an ultrasound-guided block will be performed on the surgical side with the participant in the sitting position and the hand placed on the opposite shoulder. The probe will be positioned sagittally medial to the scapula at the second and third ribs. Following hydrodissection with 2 mL of saline, a single injection of 30 mL of 0.25% bupivacaine with epinephrine at 1:200,000 will be administered into the plane between the serratus posterior superior and intercostal muscles. | Procedure or surgery | SPSIP Block |
Primary outcome
Total PCA Tramadol Consumption During the First 24 Hours After Surgery
Time frame: First 24 hours after surgery
The cumulative dose of tramadol delivered through the intravenous patient-controlled analgesia (PCA) pump during the first 24 postoperative hours will be recorded in milligrams and compared between the groups. Only tramadol actually delivered by the PCA pump will be included. Intraoperative tramadol and rescue meperidine will not be included in this outcome.
5 secondary outcomes
Postoperative Pain at Rest
Time frame: At 0, 2, 4, 8, 16, and 24 hours after surgery
Postoperative Pain During Movement
Time frame: At 0, 2, 4, 8, 16, and 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Time frame: At 24 hours after surgery
Incidence of Block-Related Complications
Time frame: From block administration through 24 hours after surgery
Incidence of Opioid-Related Adverse Effects
Time frame: First 24 hours after surgery
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 2 Nov 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
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 High Thoracic Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in people with Postoperative Pain, 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 9 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 2 Nov 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 Yusuf Alan, MD (+905396210977, dryusufalan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total PCA Tramadol Consumption During the First 24 Hours After Surgery (time frame: First 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 2 Nov 2026.