Postoperative Pain, Thoracic Anesthesia, Video Assisted Thoracic Surgery (VATS)
Conditions
Keywords
Thoracic Surgery, Video-Assisted, Analgesia, Postoperative, Morphine, Injections, Spinal, Nerve Block
Brief 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.
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.
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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative IV-MME during the first 24 hours after postoperative admission following extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative IV-MME during the first 12 hours after postoperative admission following extubation | 12 hours | Total opioid consumption during the first 12 postoperative hours expressed as intravenous morphine milligram equivalents |
| Postoperative pain scores | 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. |
| Time to first patient-controlled analgesia demand | 24 hours | Time from postoperative admission to the first PCA morphine demand. |
| Quality of recovery score | 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. |
| Postoperative nausea and vomiting | 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. |
| Sedation level | 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. |
| Respiratory depression | 24 hours | Incidence of respiratory depression defined as oxygen saturation below 90 percent or respiratory rate below 8 breaths per minute |
| Pruritus | 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. |
| Block-related complications | Up to 30 days postoperatively | Incidence of post-dural puncture headache, paresthesia, hematoma, and local anesthetic systemic toxicity associated with the study interventions. |
| Postoperative complications | 30 days | Postoperative complications assessed using the Clavien-Dindo classification, where higher grades indicate more severe complications. |
| Remifentanil consumption | Intraoperative period (from induction to end of surgery), up to 4 hours | Total intraoperative remifentanil consumption administered during surgery, measured in micrograms (µg). |
| Rescue analgesia requirement | 24 hours | Incidence of patients requiring additional analgesia beyond patient-controlled analgesia |
| Incidence of postoperative nausea and/or vomiting | 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. |
| Propofol consumption | Intraoperative period (from induction to end of surgery), up to 4 hours | Total intraoperative propofol consumption administered during surgery, measured in milligrams (mg). |
| Area under the numeric rating scale-time curve | 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. |
| Comprehensive Complication Index | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTCengiz Kaya, Prof Dr
Outcome results
None listed