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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Morphine | Experimental | Participants receive intrathecal morphine before induction of general anesthesia. Intrathecal morphine is administered at a dose of 5 micrograms per kilogram in 3 milliliters of saline via spinal injection. All patients subsequently undergo standardized general anesthesia and receive postoperative patient-controlled analgesia with intravenous 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Morphine | Procedure | Intrathecal 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption within 12 hours after surgery | Total opioid consumption during the first 12 postoperative hours expressed as intravenous morphine milligram equivalents | 12 hours |
| Postoperative pain scores |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate measured intraoperatively and postoperatively, expressed in beats per minute (bpm). | Intraoperative period (up to 4 hours) |
| Mean Arterial Pressure | Mean arterial pressure measured intraoperatively and postoperatively, expressed in millimeters of mercury (mmHg). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cengiz Kaya, Prof Dr | Contact | +905056793359 | cengiz.kaya@omu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayis University | Recruiting | Atakent | Samsun | 55270 | Turkey (Türkiye) |
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| Serratus Posterior Superior Intercostal Plane Block | Procedure | 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. |
|
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 |
| Time to first patient-controlled analgesia demand | Time from arrival in the postoperative period to first patient-controlled analgesia demand | 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. | Preoperative baseline, 24 hours postoperatively, and at discharge |
| Postoperative nausea and vomiting | Postoperative nausea and vomiting (PONV) 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. Rescue antiemetic therapy (intravenous metoclopramide) will be administered for scores >1. | 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. | 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 | 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. | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Post-dural puncture headache | Incidence of headache consistent with post-dural puncture headache | 30 days |
| Postoperative complications | Postoperative complications assessed using the Clavien-Dindo classification, where higher grades indicate more severe complications. | 30 days |
| Remifentanil consumption | 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 | Incidence of patients requiring additional analgesia beyond patient-controlled analgesia | 24 hours |
| Incidence of PONV (postoperative of 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. | 24 hours postoperatively |
| Propofol consumption | Total intraoperative propofol consumption administered during surgery, measured in milligrams (mg). | Intraoperative period (from induction to end of surgery), up to 4 hours |
| Intraoperative period (up to 4 hours) |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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