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The purpose of this study is to find out which pain relief method works better for people having video-assisted thoracoscopic surgery. We will compare two techniques: thoracic paravertebral block (TPVB), a numbing injection near the spine, and intrathecal morphine (ITM), a small dose of morphine injected into the spinal fluid. We want to see if ITM works as well as TPVB in reducing the need for pain medicine during the first 24 hours after surgery. People in the study will get either TPVB or ITM before going to sleep for surgery, use a patient-controlled pain pump after surgery, and have their pain scores, medicine use, recovery, and possible side effects checked for up to 30 days after surgery.
This study will compare two different pain control techniques for people having video-assisted thoracoscopic surgery (VATS), a minimally invasive chest operation. The first technique, called thoracic paravertebral block (TPVB), involves injecting numbing medicine near the spine to block pain from the surgical area. The second technique, intrathecal morphine (ITM), involves giving a small dose of morphine into the spinal fluid to provide pain relief after surgery.
The main goal is to find out if ITM works as well as TPVB in reducing the need for additional pain medicine during the first 24 hours after surgery. This is a randomized controlled trial, meaning participants will be randomly assigned to one of the two groups. Everyone will receive general anesthesia for their surgery and will use a patient-controlled analgesia pump afterwards, along with regular pain medicines such as paracetamol and tenoxicam.
Pain scores, the amount of pain medicine used, and recovery quality will be measured at regular times in the first 24 hours after surgery. We will also monitor side effects such as nausea, vomiting, itching, or breathing problems. All patients will be followed for 30 days after surgery to check for any complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic Paravertebral Block (TPVB) | Experimental | Patients in this group will receive a single-injection ultrasound-guided thoracic paravertebral block before induction of standardized general anesthesia. The block will be performed using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000). Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. |
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| Intrathecal Morphine (ITM) | Experimental | Patients in this group will receive a single dose of intrathecal morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperatively, patients will receive intravenous patient-controlled analgesia with morphine, along with scheduled paracetamol and NSAIDs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic paravertebral block | Procedure | Ultrasound-guided single-injection thoracic paravertebral block using 0.4 mL/kg of 0.25% bupivacaine with epinephrine (1:400,000) before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 24 Hours After Surgery | Total amount of intravenous morphine milligram equivalents (IV-MME) administered during the first 24 postoperative hours. | First 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative IV Morphine Milligram Equivalents (IV-MME) in the First 12 Hours After Surgery | Total amount of IV-MME administered during the first 12 postoperative hours. | First 12 hours postoperatively |
| Time to First Analgesic Request |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Faculty of Medicine, Ondokuz Mayis University | Samsun | Atakum | 55139 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42309548 | Derived | Kaya C, Demirkol K, Sener EB, Kocamanoglu IS, Elsharkawy H. Comparison of intrathecal morphine versus thoracic paravertebral block for video-assisted thoracoscopic surgery: a randomized non-inferiority trial. Reg Anesth Pain Med. 2026 Jun 17:rapm-2026-107927. doi: 10.1136/rapm-2026-107927. Online ahead of print. |
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De-identified individual participant data (including baseline characteristics, intraoperative and postoperative outcome measures, and adverse events) will be shared with researchers upon reasonable request for academic purposes. Data will be available beginning 6 months after publication of the primary results and for up to 5 years. Access will be granted following approval of a written proposal and data use agreement.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine | Drug | Single intrathecal injection of morphine (5 mcg/kg diluted in 3 mL 0.9% saline) at the L3-L4 or L4-L5 interspace before induction of standardized general anesthesia. Postoperative analgesia will be provided with intravenous patient-controlled analgesia morphine, along with scheduled paracetamol and NSAIDs. |
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Duration from the time the patient is extubated and able to communicate after surgery to the first patient-controlled analgesia (PCA) demand for analgesia
| From extubation and recovery of communication ability to first PCA demand, within 24 hours postoperatively |
| Numeric Rating Scale (NRS) Pain Scores at Rest | Pain intensity at rest measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively. | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Numeric Rating Scale (NRS) Pain Scores During Coughing or Deep Breathing | Pain intensity during coughing or deep breathing measured using an 11-point NRS (0 = no pain, 10 = worst pain imaginable) at 0, 3, 6, 12, 18, and 24 hours postoperatively. | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Sedation Score | Sedation Score assessed using the Ramsay Sedation Scale (1-6) at 0, 3, 6, 12, 18, and 24 hours postoperatively | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Postoperative Nausea and Vomiting (PONV) Score | Score of PONV, assessed using a 4-point scale (0 = none, 1 = nausea only, 2 = single episode of vomiting, 3 = multiple episodes of vomiting). | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Pruritus Score | Score of pruritus, assessed using a 4-point scale (0-3; 0 none, 1 mild/no treatment, 2 moderate/treatment, 3 severe/repeat treatment; treatment threshold ≥2) | 0, 3, 6, 12, 18, and 24 hours postoperatively |
| Rescue Analgesia Requirement | Number of participants requiring additional analgesics beyond PCA during the first 24 hours postoperatively. | First 24 hours postoperatively |
| Incidence of Postoperative Complications | Number of participants experiencing any postoperative complication within 30 days | First 30 postoperative days |
| Quality of Recovery questionnaire (QoR-15) score | Recovery quality wil be assessed with the validated Turkish QoR-15 (15 items; total 0-150, higher scores = better recovery). | Preoperative baseline (≤24 h before surgery), 24 h postoperatively, and at hospital discharge (anticipated within 3 days) |
| Intraoperative Remifentanil and Propofol Consumption | Total intraoperative doses of remifentanil and propofol administered by the anesthesia team will be recorded. | Intraoperative period (from induction to 240 min) |
| Intraoperative Hemodynamics (Heart Rate and Mean Arterial Pressure) | Heart rate and mean arterial pressure will be recorded at standard clinical intervals. | Intraoperative period (from induction to 240 min) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |