Pain, PostoperativeNCT06423677
Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies
A study testing Serratus Posterior Superior Intercostal Plane Block in people with Pain, Postoperative and Shoulder Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Shoulder Pain, Block
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtaining consent from the patient and their relative
- ASA score of I-II
- No bleeding diathesis
- No history of anticoagulant use
- No history of neuropathic diseases such as Diabetes Mellitus
- Patients aged 18-65 years undergoing shoulder arthroscopy surgery
Who cannot join
- Lack of consent from the patient or their relative
- Patients with an ASA score of III or above
- Patients with a history of bleeding diathesis
- Conditions where regional anesthesia is contraindicated
- Patients with a history of neuropathic diseases
- Patients under 18 years or over 65 years of age
- Patients with a history of allergies to the aforementioned medications
- Patients with an infection at the site where the block will be administered
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303
About this study
Official title: Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner.
Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.
Read the detailed description
Patient Positioning and Preparation:
Patient Positioning:
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. This positioning facilitates access to the block site and ensures patient comfort.
Aseptic Technique:
The block site will be prepared by wiping it three times with 10% povidone-iodine to ensure asepsis.
The linear ultrasound probe will be covered in a sterile manner to prevent contamination during the procedure.
Ultrasound-Guided Block Procedure:
Probe Placement and Rib Identification:
The Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side.
The probe will be slid medially to identify the 2nd and 3rd ribs on the medial side of the scapular spine. Accurate identification of these ribs is crucial for proper needle placement.
Needle Insertion and Block Site Confirmation:
A block needle will be advanced under ultrasound guidance onto the 3rd rib. The ultrasound guidance ensures precise needle placement, minimizing the risk of complications.
Once the needle contacts the rib, it will be retracted by 1mm. This slight retraction helps position the needle tip correctly for optimal drug delivery.
The block site will be confirmed by injecting sterile 0.9% NaCl. The spread of saline under ultrasound visualization confirms the correct location.
Anesthetic Administration:
Following confirmation of the block site, 30ml of 0.25% bupivacaine will be administered in a controlled manner. The controlled administration ensures a steady and effective distribution of the anesthetic agent.
Perioperative Analgesia Management:
Pre-Awakening Medication:
Before awakening from surgery, both the block group and the non-block group will receive:
1g of paracetamol intravenously.
1mg/kg of tramadol intravenously.
Postoperative Analgesia:
Postoperative analgesia will be managed using a multimodal approach, including:
Intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl.
The PCA will be set with no basal infusion, allowing patients to self-administer bolus doses of 20mg with a lockout period of 20 minutes.
The total dose limitation will be set at 200mg over 4 hours to prevent overdose and manage pain effectively.
Postoperative Assessment and Follow-Up:
VAS Score Monitoring:
Patients will be visited at the following time intervals postoperatively: 0, 1, 6, 12, and 24 hours.
During each visit, patients will be asked to record their pain levels using the visual analog scale (VAS) on a paper scale. This subjective measure provides valuable insight into the patient's pain experience.
Opioid Consumption and Rescue Analgesia:
The amount of opioid used via PCA will be recorded to evaluate opioid consumption.
The need for rescue analgesia will be assessed and documented. If required, patients will receive 50mg of Arveles intravenously.
Routine Postoperative Medication:
All patients will receive routine postoperative medication, including 4x1g paracetamol to maintain baseline analgesia and reduce overall opioid requirements.
Randomization Process:
Randomization Protocol:
Patients scheduled for surgery will be randomly assigned to either the block group or the non-block group to ensure unbiased allocation and comparability between groups.
Randomization will be performed using a computer-generated random number sequence, ensuring that each patient has an equal chance of being allocated to either group.
Allocation concealment will be maintained by using opaque, sealed envelopes containing the group assignments. These envelopes will only be opened after patient consent and immediately before the block procedure.
Blinding:
The study will implement a single-blind design where the patients will be unaware of their group assignment to minimize bias in self-reported outcomes.
The healthcare providers responsible for postoperative care and outcome assessment will also be blinded to the group allocation to ensure objective evaluation of the study endpoints.
- Conditions
- Pain, Postoperative, Shoulder Pain, Block
- Being tested
- Serratus Posterior Superior Intercostal Plane Block, patient controlled analgesia
- Medical subject headings
- Pain, Postoperative, Shoulder Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
The Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner.
patient controlled analgesiaDevice
intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| serratus posterior superior intercostal plane block + intravenous patient controlled analgesia | Active comparator | serratus posterior superior intercostal plane block will be administered to these group. after the extubation intravenous patient controlled analgesia (PCA) will also be administered to patients. Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block; Device: patient controlled analgesia |
| intravenous patient controlled analgesia | Active comparator | After the extubation, only intravenous patient controlled analgesia (PCA) will be administered to patients. Receives: Device: patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale score
Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.
Measured: 0, 1, 6, 12, and 24 hours
opioid consumption
Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.
Measured: 0, 1, 6, 12, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start25 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Engin ihsan Turan, Principal investigator, Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423677
- Sponsor's protocol ID
- Serratus Posterior Superior
- Status last verified
- Jan 2025
- First submitted
- 16 May 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06423677
- Acronym / sponsor ID
- Serratus Posterior Superior
- Conditions
- Pain, Postoperative, Shoulder Pain, Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 May 2024 (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.
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner.
Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.
Detailed description
Patient Positioning and Preparation:
Patient Positioning:
Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. This positioning facilitates access to the block site and ensures patient comfort.
Aseptic Technique:
The block site will be prepared by wiping it three times with 10% povidone-iodine to ensure asepsis.
The linear ultrasound probe will be covered in a sterile manner to prevent contamination during the procedure.
Ultrasound-Guided Block Procedure:
Probe Placement and Rib Identification:
The Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side.
The probe will be slid medially to identify the 2nd and 3rd ribs on the medial side of the scapular spine. Accurate identification of these ribs is crucial for proper needle placement.
Needle Insertion and Block Site Confirmation:
A block needle will be advanced under ultrasound guidance onto the 3rd rib. The ultrasound guidance ensures precise needle placement, minimizing the risk of complications.
Once the needle contacts the rib, it will be retracted by 1mm. This slight retraction helps position the needle tip correctly for optimal drug delivery.
The block site will be confirmed by injecting sterile 0.9% NaCl. The spread of saline under ultrasound visualization confirms the correct location.
Anesthetic Administration:
Following confirmation of the block site, 30ml of 0.25% bupivacaine will be administered in a controlled manner. The controlled administration ensures a steady and effective distribution of the anesthetic agent.
Perioperative Analgesia Management:
Pre-Awakening Medication:
Before awakening from surgery, both the block group and the non-block group will receive:
1g of paracetamol intravenously.
1mg/kg of tramadol intravenously.
Postoperative Analgesia:
Postoperative analgesia will be managed using a multimodal approach, including:
Intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl.
The PCA will be set with no basal infusion, allowing patients to self-administer bolus doses of 20mg with a lockout period of 20 minutes.
The total dose limitation will be set at 200mg over 4 hours to prevent overdose and manage pain effectively.
Postoperative Assessment and Follow-Up:
VAS Score Monitoring:
Patients will be visited at the following time intervals postoperatively: 0, 1, 6, 12, and 24 hours.
During each visit, patients will be asked to record their pain levels using the visual analog scale (VAS) on a paper scale. This subjective measure provides valuable insight into the patient's pain experience.
Opioid Consumption and Rescue Analgesia:
The amount of opioid used via PCA will be recorded to evaluate opioid consumption.
The need for rescue analgesia will be assessed and documented. If required, patients will receive 50mg of Arveles intravenously.
Routine Postoperative Medication:
All patients will receive routine postoperative medication, including 4x1g paracetamol to maintain baseline analgesia and reduce overall opioid requirements.
Randomization Process:
Randomization Protocol:
Patients scheduled for surgery will be randomly assigned to either the block group or the non-block group to ensure unbiased allocation and comparability between groups.
Randomization will be performed using a computer-generated random number sequence, ensuring that each patient has an equal chance of being allocated to either group.
Allocation concealment will be maintained by using opaque, sealed envelopes containing the group assignments. These envelopes will only be opened after patient consent and immediately before the block procedure.
Blinding:
The study will implement a single-blind design where the patients will be unaware of their group assignment to minimize bias in self-reported outcomes.
The healthcare providers responsible for postoperative care and outcome assessment will also be blinded to the group allocation to ensure objective evaluation of the study endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serratus posterior superior intercostal plane block + intravenous patient controlled analgesia | Active comparator | Procedure: Serratus Posterior Superior Intercostal Plane Block, Device: patient controlled analgesiaserratus posterior superior intercostal plane block will be administered to these group. after the extubation intravenous patient controlled analgesia (PCA) will also be administered to patients. |
| intravenous patient controlled analgesia | Active comparator | Device: patient controlled analgesiaAfter the extubation, only intravenous patient controlled analgesia (PCA) will be administered to patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Obtaining consent from the patient and their relative
- ASA score of I-II
- No bleeding diathesis
- No history of anticoagulant use
- No history of neuropathic diseases such as Diabetes Mellitus
Key exclusion criteria (8 listed)
- Lack of consent from the patient or their relative
- Patients with an ASA score of III or above
- Patients with a history of bleeding diathesis
- Conditions where regional anesthesia is contraindicated
- Patients with a history of neuropathic diseases
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockThe Serratus Posterior Superior Intercostal Plane Block will be performed under ultrasound guidance. During the block, a linear ultrasound probe will be placed parallel to the spine of the scapula on the surgical side and then slid medially. The block needle will be advanced under ultrasound guidance over the 3rd rib. After the needle touches the rib, it will be withdrawn by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 50mg of bupivacaine and 100mg of lidocaine in a controlled manner. | Procedure or surgery | serratus posterior superior intercostal plane block + intravenous patient controlled analgesia |
| patient controlled analgesiaintravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours | Device | intravenous patient controlled analgesia, serratus posterior superior intercostal plane block + intravenous patient controlled analgesia |
Primary outcome
visual analog scale score
Time frame: 0, 1, 6, 12, and 24 hours
Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.
opioid consumption
Time frame: 0, 1, 6, 12, and 24 hours
Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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. This study is not recruiting at the moment.
Engin ihsan Turan principal investigator
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training 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 Serratus Posterior Superior Intercostal Plane Block in people with Pain, Postoperative and Shoulder Pain, run by Kanuni Sultan Suleyman Training and Research Hospital 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 24 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale score (time frame: 0, 1, 6, 12, and 24 hours). The study lists 2 primary outcomes in all. 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 24 Jan 2025.