Thoracic AnesthesiaNCT07540104
Serratus Posterior Superior Intercostal Plane Block Versus Intrathecal Morphine in VATS
A study testing Intrathecal Morphine and Serratus Posterior Superior Intercostal Plane Block in people with Thoracic Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Anesthesia, Postoperative Pain, Video Assisted Thoracic Surgery (VATS)
- What is being tested?
- Intrathecal Morphine 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
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Sep 2026
- 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 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 video-assisted thoracoscopic surgery, including wedge resection, segmentectomy, or lobectomy
Who cannot join
- Refusal to participate
- Pregnancy
- Morbid obesity (body mass index greater than 40 kg per square meter)
- Allergy to study medications
- Neuropsychiatric disorders, cognitive impairment, or inability to communicate
- History of substance abuse
Show all 13Show fewer
- Active systemic infection or infection at the planned injection site
- Severe cardiac, respiratory, hepatic, renal, or endocrine disease.
- Chronic pain syndrome or ongoing chronic pain treatment
- Emergency surgery or previous ipsilateral VATS or thoracotomy
- Preoperative opioid use: ≥15 mg oral morphine equivalents/day for ≥30 days within the previous 3 months.
- Anticipated need for postoperative mechanical ventilation.
- Contraindications to neuraxial or peripheral regional anesthesia, including anticoagulant therapy, coagulopathy, infection, or relevant anatomical abnormalities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Atakent, Samsun, 55270
About this study
Official title: Comparison of the Effects of Serratus Posterior Superior Intercostal Plane Block and Intrathecal Morphine on Postoperative Acute Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery
This study aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
This is a prospective, randomized, controlled, single-center clinical trial including adult patients undergoing elective thoracoscopic surgery. Participants will be randomly assigned to receive either a serratus posterior superior intercostal plane block or intrathecal morphine before general anesthesia.
Read more
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents. Secondary outcomes include pain scores, time to first analgesic request, quality of recovery, and postoperative complications.
The study aims to determine whether these two techniques differ in their effectiveness for postoperative pain management.
Read the detailed description
This study is a prospective, randomized, controlled, single-blinded, parallel-group clinical trial designed to compare the analgesic efficacy of serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
Eligible patients aged 18-75 years with American Society of Anesthesiologists physical status I-III scheduled for elective thoracoscopic procedures (wedge resection, segmentectomy, or lobectomy) will be included. Patients will be randomized in a 1:1 ratio using a computer-generated sequence with block randomization.
Participants in the serratus posterior superior intercostal plane block group will receive an ultrasound-guided regional block prior to the induction of general anesthesia. Participants in the intrathecal morphine group will receive an intrathecal morphine injection before general anesthesia. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia.
The primary outcome is cumulative opioid consumption within the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents.
Secondary outcomes include opioid consumption at 12 hours, numeric rating scale pain scores at rest and during activity, time to first analgesic request, quality of recovery scores, postoperative nausea and vomiting, sedation levels, pruritus, respiratory depression, and postoperative complications up to 30 days.
This study aims to evaluate the relative effectiveness of these two analgesic techniques and to improve postoperative pain management strategies in thoracic surgery.
- Being tested
- Intrathecal Morphine, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Thoracic Surgery, Video-Assisted, Analgesia, Postoperative, Morphine, Injections, Spinal, Nerve Block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineProcedure or surgery
Preservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally before induction of general anesthesia.
Serratus Posterior Superior Intercostal Plane BlockProcedure or surgery
Ultrasound-guided serratus posterior superior intercostal plane block is performed before induction of general anesthesia using 30 milliliters of 0.25 percent bupivacaine with epinephrine injected into the interfascial plane between the serratus posterior superior muscle and intercostal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Morphine | Experimental | Participants receive intrathecal morphine before induction of general anesthesia. Preservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine. Receives: Procedure: Intrathecal Morphine |
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Participants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia. A total of 30 milliliters of 0.25 percent bupivacaine with epinephrine is administered into the interfascial plane between the serratus posterior superior muscle and intercostal muscles. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine. 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.
Cumulative IV-MME during the first 24 hours after postoperative admission following extubation
Total opioid consumption during the first 24 postoperative hours is expressed as intravenous morphine milligram equivalents, including patient-controlled analgesia and rescue analgesia.
Measured: 24 hours
Secondary outcomes (16)
Cumulative IV-MME during the first 12 hours after postoperative admission following extubation
Total opioid consumption during the first 12 postoperative hours expressed as intravenous morphine milligram equivalents
Measured: 12 hours
Postoperative pain scores
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0-10), where higher scores indicate greater pain intensity, with 0 representing no pain and 10 representing the worst imaginable pain, measured at rest and during activity.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Time to first patient-controlled analgesia demand
Time from postoperative admission to the first PCA morphine demand.
Measured: 24 hours
Quality of recovery score
Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15; total score range 0-150), a validated patient-reported outcome measure where higher scores indicate better postoperative recovery.
Measured: Preoperative baseline, 24 hours postoperatively, and at discharge
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV) will be assessed using a 4-point ordinal scale (0-3), where 0 indicates no nausea or vomiting, 1 indicates nausea without vomiting, 2 indicates a single episode of vomiting, and 3 indicates multiple episodes of vomiting; higher scores indicate worse symptoms. Scores >1 will be treated with ondansetron 4 mg IV; persistent symptoms will be treated with intravenous metoclopramide.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Sedation level
Sedation level assessed using the Ramsay Sedation Scale (RSS; 1-6), a validated ordinal scale where higher scores indicate deeper sedation, with 1 representing anxiety/agitation and 6 representing no response to stimuli.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Respiratory depression
Incidence of respiratory depression defined as oxygen saturation below 90 percent or respiratory rate below 8 breaths per minute
Measured: 24 hours
Pruritus
Incidence and severity of postoperative pruritus assessed using a 4-point ordinal scale (0-3), where 0 = no pruritus, 1 = mild pruritus (itching without scratching), 2 = moderate pruritus (itching with scratching), and 3 = severe pruritus requiring treatment; higher scores indicate worse symptoms.
Measured: 0, 3, 6, 12, 18, and 24 hours postoperatively
Block-related complications
Incidence of post-dural puncture headache, paresthesia, hematoma, and local anesthetic systemic toxicity associated with the study interventions.
Measured: Up to 30 days postoperatively
Postoperative complications
Postoperative complications assessed using the Clavien-Dindo classification, where higher grades indicate more severe complications.
Measured: 30 days
Remifentanil consumption
Total intraoperative remifentanil consumption administered during surgery, measured in micrograms (µg).
Measured: Intraoperative period (from induction to end of surgery), up to 4 hours
Rescue analgesia requirement
Incidence of patients requiring additional analgesia beyond patient-controlled analgesia
Measured: 24 hours
Incidence of postoperative nausea and/or vomiting
Incidence of postoperative nausea and vomiting (PONV), defined as the occurrence of at least one episode of nausea and/or vomiting within the first 24 hours postoperatively (yes/no). Patients experiencing at least one episode will be classified as having PONV.
Measured: 24 hours postoperatively
Propofol consumption
Total intraoperative propofol consumption administered during surgery, measured in milligrams (mg).
Measured: Intraoperative period (from induction to end of surgery), up to 4 hours
Area under the numeric rating scale-time curve
The area under the numeric rating scale-time curve from 0 to 24 postoperative hours will be calculated separately for pain at rest and during activity using pain scores measured at 0, 3, 6, 12, 18, and 24 hours and the trapezoidal rule. Higher values indicate a greater cumulative pain burden.
Measured: 0 to 24 hours postoperatively
Comprehensive Complication Index
Overall postoperative morbidity will be quantified using the Comprehensive Complication Index, which integrates all postoperative complications graded according to the Clavien-Dindo classification into a continuous score ranging from 0 to 100. Higher scores indicate greater overall morbidity.
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026
- Primary completion15 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz KAYA, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540104
- Sponsor's protocol ID
- SPSIPITM1
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Serratus Posterior Superior Intercostal Plane Block and Intrathecal Morphine on Postoperative Acute Pain in Patients Undergoing Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT07540104
- Acronym / sponsor ID
- SPSIPITM1
- Keywords
- Thoracic Surgery, Video-Assisted, Analgesia, Postoperative, Morphine, Injections, Spinal, Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 20 Apr 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 aims to compare the analgesic effects of the serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
This is a prospective, randomized, controlled, single-center clinical trial including adult patients undergoing elective thoracoscopic surgery. Participants will be randomly assigned to receive either a serratus posterior superior intercostal plane block or intrathecal morphine before general anesthesia.
The primary outcome is cumulative opioid consumption during the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents. Secondary outcomes include pain scores, time to first analgesic request, quality of recovery, and postoperative complications.
The study aims to determine whether these two techniques differ in their effectiveness for postoperative pain management.
Detailed description
This study is a prospective, randomized, controlled, single-blinded, parallel-group clinical trial designed to compare the analgesic efficacy of serratus posterior superior intercostal plane block and intrathecal morphine in patients undergoing video-assisted thoracoscopic surgery.
Eligible patients aged 18-75 years with American Society of Anesthesiologists physical status I-III scheduled for elective thoracoscopic procedures (wedge resection, segmentectomy, or lobectomy) will be included. Patients will be randomized in a 1:1 ratio using a computer-generated sequence with block randomization.
Participants in the serratus posterior superior intercostal plane block group will receive an ultrasound-guided regional block prior to the induction of general anesthesia. Participants in the intrathecal morphine group will receive an intrathecal morphine injection before general anesthesia. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia.
The primary outcome is cumulative opioid consumption within the first 24 postoperative hours, expressed as intravenous morphine milligram equivalents.
Secondary outcomes include opioid consumption at 12 hours, numeric rating scale pain scores at rest and during activity, time to first analgesic request, quality of recovery scores, postoperative nausea and vomiting, sedation levels, pruritus, respiratory depression, and postoperative complications up to 30 days.
This study aims to evaluate the relative effectiveness of these two analgesic techniques and to improve postoperative pain management strategies in thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Morphine | Experimental | Procedure: Intrathecal MorphineParticipants receive intrathecal morphine before induction of general anesthesia. Preservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine. |
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane BlockParticipants receive an ultrasound-guided serratus posterior superior intercostal plane block before induction of general anesthesia. A total of 30 milliliters of 0.25 percent bupivacaine with epinephrine is administered into the interfascial plane between the serratus posterior superior muscle and intercostal muscles. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous morphine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective video-assisted thoracoscopic surgery, including wedge resection, segmentectomy, or lobectomy
Key exclusion criteria (13 listed)
- Refusal to participate
- Pregnancy
- Morbid obesity (body mass index greater than 40 kg per square meter)
- Allergy to study medications
- Neuropsychiatric disorders, cognitive impairment, or inability to communicate
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 |
|---|---|---|
| Intrathecal MorphinePreservative-free morphine at 5 µg/kg based on ideal body weight is diluted with 0.9% saline to a total volume of 3 mL and administered intrathecally before induction of general anesthesia. | Procedure or surgery | Intrathecal Morphine |
| Serratus Posterior Superior Intercostal Plane BlockUltrasound-guided serratus posterior superior intercostal plane block is performed before induction of general anesthesia using 30 milliliters of 0.25 percent bupivacaine with epinephrine injected into the interfascial plane between the serratus posterior superior muscle and intercostal muscles. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block |
Primary outcome
Cumulative IV-MME during the first 24 hours after postoperative admission following extubation
Time frame: 24 hours
Total opioid consumption during the first 24 postoperative hours is expressed as intravenous morphine milligram equivalents, including patient-controlled analgesia and rescue analgesia.
16 secondary outcomes
Cumulative IV-MME during the first 12 hours after postoperative admission following extubation
Time frame: 12 hours
Postoperative pain scores
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Time to first patient-controlled analgesia demand
Time frame: 24 hours
Quality of recovery score
Time frame: Preoperative baseline, 24 hours postoperatively, and at discharge
Postoperative nausea and vomiting
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Sedation level
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Respiratory depression
Time frame: 24 hours
Pruritus
Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
Block-related complications
Time frame: Up to 30 days postoperatively
Postoperative complications
Time frame: 30 days
Remifentanil consumption
Time frame: Intraoperative period (from induction to end of surgery), up to 4 hours
Rescue analgesia requirement
Time frame: 24 hours
Incidence of postoperative nausea and/or vomiting
Time frame: 24 hours postoperatively
Propofol consumption
Time frame: Intraoperative period (from induction to end of surgery), up to 4 hours
Area under the numeric rating scale-time curve
Time frame: 0 to 24 hours postoperatively
Comprehensive Complication Index
Time frame: Up to 30 days postoperatively
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 5 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine and Serratus Posterior Superior Intercostal Plane Block in people with Thoracic Anesthesia and Postoperative Pain, run by Ondokuz Mayıs University 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 3 inclusion and 13 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 5 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?
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?
Cumulative IV-MME during the first 24 hours after postoperative admission following extubation (time frame: 24 hours). 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 5 Oct 2026.