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RecruitingNCT07540104Updated Aug 10, 2026

Serratus Posterior Superior Intercostal Plane Block Versus Intrathecal Morphine in VATS

An interventional study of Intrathecal Morphine and Serratus Posterior Superior Intercostal Plane Block in Thoracic Anesthesia, Postoperative Pain and Video Assisted Thoracic Surgery (VATS), sponsored by Ondokuz Mayıs University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Thoracic Anesthesia
  • Postoperative Pain
  • Video Assisted Thoracic Surgery (VATS)

Keywords

  • Thoracic Surgery, Video-Assisted
  • Analgesia, Postoperative
  • Morphine
  • Injections, Spinal
  • Nerve Block
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intrathecal Morphine

    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.

    Procedure: Intrathecal Morphine

  • Experimental
    Serratus Posterior Superior Intercostal Plane Block

    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.

    Procedure: Serratus Posterior Superior Intercostal Plane Block

Interventions

  • ProcedureIntrathecal Morphine

    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.

  • ProcedureSerratus Posterior Superior Intercostal Plane Block

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. 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

    Time frame: 12 hours

  2. 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.

    Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively

  3. Time to first patient-controlled analgesia demand

    Time from postoperative admission to the first PCA morphine demand.

    Time frame: 24 hours

  4. 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.

    Time frame: Preoperative baseline, 24 hours postoperatively, and at discharge

  5. 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.

    Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively

  6. 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.

    Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively

  7. Respiratory depression

    Incidence of respiratory depression defined as oxygen saturation below 90 percent or respiratory rate below 8 breaths per minute

    Time frame: 24 hours

  8. 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.

    Time frame: 0, 3, 6, 12, 18, and 24 hours postoperatively

  9. Block-related complications

    Incidence of post-dural puncture headache, paresthesia, hematoma, and local anesthetic systemic toxicity associated with the study interventions.

    Time frame: Up to 30 days postoperatively

  10. Postoperative complications

    Postoperative complications assessed using the Clavien-Dindo classification, where higher grades indicate more severe complications.

    Time frame: 30 days

  11. Remifentanil consumption

    Total intraoperative remifentanil consumption administered during surgery, measured in micrograms (µg).

    Time frame: Intraoperative period (from induction to end of surgery), up to 4 hours

  12. Rescue analgesia requirement

    Incidence of patients requiring additional analgesia beyond patient-controlled analgesia

    Time frame: 24 hours

  13. 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.

    Time frame: 24 hours postoperatively

  14. Propofol consumption

    Total intraoperative propofol consumption administered during surgery, measured in milligrams (mg).

    Time frame: Intraoperative period (from induction to end of surgery), up to 4 hours

  15. 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.

    Time frame: 0 to 24 hours postoperatively

  16. 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.

    Time frame: Up to 30 days postoperatively

06

Study locations

1 of 1 sites recruiting
  • Ondokuz Mayis University
    Atakent, Samsun 55270, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT07540104
Lead sponsor
Ondokuz Mayıs University
Responsible party
Cengiz KAYA (Prof. Dr., Ondokuz Mayıs University) — Principal investigator
First posted
Apr 20, 2026
Start date
Apr 15, 2026
Primary completion
Aug 15, 2026 (estimated)
Completion
Sep 15, 2026 (estimated)
Last update
Aug 10, 2026

Study contacts

Cengiz Kaya, Prof Dr
Contact
cengiz.kaya@omu.edu.tr
+905056793359

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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