- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540104
Serratus Posterior Superior Intercostal Plane Block Versus Intrathecal Morphine in VATS
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cengiz Kaya, Prof Dr
- Phone Number: +905056793359
- Email: cengiz.kaya@omu.edu.tr
Study Locations
-
-
Samsun
-
Atakent, Samsun, Turkey (Türkiye), 55270
- Recruiting
- Ondokuz Mayis University
-
Contact:
- Cengiz Kaya
- Phone Number: 05056793359
- Email: raufemre@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores
Time Frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
|
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.
|
0, 3, 6, 12, 18, and 24 hours postoperatively
|
|
Quality of recovery score
Time Frame: Preoperative baseline, 24 hours postoperatively, and at discharge
|
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.
|
Preoperative baseline, 24 hours postoperatively, and at discharge
|
|
Sedation level
Time Frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
|
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.
|
0, 3, 6, 12, 18, and 24 hours postoperatively
|
|
Respiratory depression
Time Frame: 24 hours
|
Incidence of respiratory depression defined as oxygen saturation below 90 percent or respiratory rate below 8 breaths per minute
|
24 hours
|
|
Pruritus
Time Frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
|
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.
|
0, 3, 6, 12, 18, and 24 hours postoperatively
|
|
Postoperative complications
Time Frame: 30 days
|
Postoperative complications assessed using the Clavien-Dindo classification, where higher grades indicate more severe complications.
|
30 days
|
|
Remifentanil consumption
Time Frame: Intraoperative period (from induction to end of surgery), up to 4 hours
|
Total intraoperative remifentanil consumption administered during surgery, measured in micrograms (µg).
|
Intraoperative period (from induction to end of surgery), up to 4 hours
|
|
Rescue analgesia requirement
Time Frame: 24 hours
|
Incidence of patients requiring additional analgesia beyond patient-controlled analgesia
|
24 hours
|
|
Propofol consumption
Time Frame: Intraoperative period (from induction to end of surgery), up to 4 hours
|
Total intraoperative propofol consumption administered during surgery, measured in milligrams (mg).
|
Intraoperative period (from induction to end of surgery), up to 4 hours
|
|
Cumulative IV-MME during the first 12 hours after postoperative admission following extubation
Time Frame: 12 hours
|
Total opioid consumption during the first 12 postoperative hours expressed as intravenous morphine milligram equivalents
|
12 hours
|
|
Time to first patient-controlled analgesia demand
Time Frame: 24 hours
|
Time from postoperative admission to the first PCA morphine demand.
|
24 hours
|
|
Postoperative nausea and vomiting
Time Frame: 0, 3, 6, 12, 18, and 24 hours postoperatively
|
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.
|
0, 3, 6, 12, 18, and 24 hours postoperatively
|
|
Block-related complications
Time Frame: Up to 30 days postoperatively
|
Incidence of post-dural puncture headache, paresthesia, hematoma, and local anesthetic systemic toxicity associated with the study interventions.
|
Up to 30 days postoperatively
|
|
Incidence of postoperative nausea and/or vomiting
Time Frame: 24 hours postoperatively
|
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.
|
24 hours postoperatively
|
|
Area under the numeric rating scale-time curve
Time Frame: 0 to 24 hours postoperatively
|
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.
|
0 to 24 hours postoperatively
|
|
Comprehensive Complication Index
Time Frame: Up to 30 days postoperatively
|
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.
|
Up to 30 days postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Intraoperative period (up to 4 hours)
|
Heart rate measured intraoperatively and postoperatively, expressed in beats per minute (bpm).
|
Intraoperative period (up to 4 hours)
|
|
Mean Arterial Pressure
Time Frame: Intraoperative period (up to 4 hours)
|
Mean arterial pressure measured intraoperatively and postoperatively, expressed in millimeters of mercury (mmHg).
|
Intraoperative period (up to 4 hours)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPSIPITM1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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