Serratus Posterior Superior Intercostal Plane Block Versus Intrathecal Morphine in VATs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOndokuz Mayıs University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate
Pregnancy
Morbid obesity (body mass index greater than 40 kg per square meter)
Allergy to opioids, local anesthetics, or nonsteroidal anti-inflammatory drugs
Trial design
Design model
Parallel
Treatments tested in this trial
Intrathecal Morphine
Procedure/SurgeryIntrathecal morphine is administered at a dose of 5 micrograms per kilogram diluted in 3 milliliters of saline via spinal injection at the lumbar level before induction of general anesthesia.
Serratus Posterior Superior Intercostal Plane Block
Procedure/SurgeryUltrasound-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Intrathecal MorphineExperimental treatment 1 intervention
Group B: Serratus Posterior Superior Intercostal Plane BlockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative opioid consumption within 24 hours after surgery
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 hoursSecondary outcomes
1
Cumulative opioid consumption within 12 hours after surgery
Total opioid consumption during the first 12 postoperative hours expressed as intravenous morphine milligram equivalents
Time frame
12 hours2
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 postoperatively3
Time to first patient-controlled analgesia demand
Time from arrival in the postoperative period to first patient-controlled analgesia demand
Time frame
24 hours4
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 dischargeOther outcomes
1
Heart Rate
Heart rate measured intraoperatively and postoperatively, expressed in beats per minute (bpm).
Time frame
Intraoperative period (up to 4 hours)2
Mean Arterial Pressure
Mean arterial pressure measured intraoperatively and postoperatively, expressed in millimeters of mercury (mmHg).
Time frame
Intraoperative period (up to 4 hours)Sponsors and contacts
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Source ClinicalTrials.gov