Intrathecal Morphine for Recovery and Outcomes After VATS (IMPROVE-VATS)

The Effects of Intrathecal Morphine in Addition to Serratus Anterior Plane Block and Dexmedetomidine on Postoperative Recovery (QoR-15) and Systemic Inflammation in Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial

This study will compare two different methods of pain management in patients undergoing video-assisted thoracoscopic surgery (VATS). One group will receive a combination of spinal morphine, nerve block, and dexmedetomidine, while the other group will receive a nerve block and dexmedetomidine without spinal morphine. All patients will receive standard pain medications after surgery. The purpose is to see if adding spinal morphine improves pain control and recovery after surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery
• Intervention / Treatment: Drug: Intrathecal Morphine; Procedure: Serratus Anterior Plane Block (SAPB) group; Drug: Dexmedetomidine

Detailed Description

This is a single-center, prospective, randomized, double-blind clinical trial evaluating the efficacy of intrathecal morphine in combination with serratus anterior plane block (SAPB) and dexmedetomidine infusion for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS). Eligible patients are ASA I-II, aged 18-70 years, with BMI < 35 kg/m². Patients will be randomized into two groups using a computer-generated sequence. The intervention group will receive intrathecal morphine (200 µg) in addition to SAPB and dexmedetomidine, while the control group will receive SAPB and dexmedetomidine alone. The primary outcome is postoperative pain scores (VAS) within the first 24 hours. Secondary outcomes include opioid consumption, quality of recovery, and incidence of side effects.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Akif Yılmaz, assistant doctor; Phone Number: +90 534 653 35 39; Email: mehmetakifyilmaz025@gmail.com
• Study Contact Backup: Name: İrem Ateş Associate Professor (Doçent Doktor); Phone Number: +90 532 740 12 58; Email: driremates@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Erzurum, Turkey (Türkiye), 25000
    • Recruiting
    • Ataturk University
    • Contact: Mehmet Akif Yılmaz, assistant doctor; Phone Number: +90 534 653 35 39; Email: mehmetakifyilmaz025@gmail.com
  • Erzurum, Turkey (Türkiye), 25240
    • Recruiting
    • Ataturk University
    • Contact: Mehmet Akif Yilmaz; Phone Number: 05346533539; Email: mehmetakifyilmaz025@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective video-assisted thoracoscopic surgery (VATS) planned
• Age 18-70 years
• ASA physical status I-III
• Body mass index (BMI) <35 kg/m²

Exclusion Criteria:

• Coagulopathy
• Opioid dependence or intolerance
• Allergy to local anesthetics
• Contraindications to neuraxial blockade
• Chronic pain history
• Renal or hepatic failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITM + SAPB + Dex; Before induction, 200 µg intrathecal morphine via a 27G Sprotte spinal needle from L3-L4; intraoperative 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg/kg loading (15 min) followed by a 0.5 µg/kg/h infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine under ultrasound guidance at the end of surgery; basal tramadol PCA without infusion IV in the PACU (20 mg each bolus, maximum 200 mg/24 h); if necessary, 50 mg tramadol IV for VAS>4.	Drug: Intrathecal Morphine; 200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.; Procedure: Serratus Anterior Plane Block (SAPB) group; Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.; Drug: Dexmedetomidine; Loading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.
Active Comparator: SAPB + Dex (No ITM); Same protocol, but no intrathecal morphine. Intraoperatively, 1 g paracetamol IV and 50 mg dexketoprofen IV; dexmedetomidine 0.5 µg/kg loading dose (15 min) followed by a 0.5 µg/kg/h infusion; unilateral SAPB with 30 mL of 0.25% bupivacaine at the end of surgery; basal intravenous tramadol PCA (20 mg each bolus, maximum 200 mg/24 h) in the PACU; if necessary, 50 mg tramadol IV for VAS >4.	Procedure: Serratus Anterior Plane Block (SAPB) group; Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.; Drug: Dexmedetomidine; Loading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-15 (QoR-15) Score	The Quality of Recovery-15 (QoR-15) questionnaire is a validated 15-item instrument that assesses patient-centered postoperative recovery, including pain, physical comfort, emotional state, and overall wellbeing. The total score ranges from 0 to 150, with higher scores indicating better recovery.	Measured 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Rescue Opioid	Duration (in hours) from the end of surgery to the first administration of rescue opioid (intravenous tramadol) when the Visual Analog Scale (VAS) pain score exceeds 4.	Within 24 hours postoperatively
Postoperative Pain Scores (VAS)	Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Both active (movement) and passive (rest) VAS scores will be recorded at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours after surgery. Higher scores indicate more severe pain.	From postoperative hour 2 to hour 24.
Total Opioid Consumption	Cumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.	24 hours postoperatively
Intraoperative Complications	Occurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.	During surgery
Postoperative Adverse Effects	Incidence of nausea, vomiting, pruritus, respiratory depression, or other opioid-related side effects during the first 24 hours postoperatively.	24 hours postoperatively
Serum Interleukin-6 (IL-6) Level	Serum IL-6 levels (pg/mL) will be measured to evaluate the systemic inflammatory response associated with surgical stress.	Preoperatively and at 24 hours postoperatively
Neutrophil-to-Lymphocyte Ratio (NLR)	The neutrophil-to-lymphocyte ratio (NLR) will be calculated to evaluate postoperative inflammatory status and its correlation with pain intensity and functional recovery.	Preoperatively and at 24 hours postoperatively
Serum C-reactive Protein (CRP) Level	Serum CRP levels (mg/L) will be measured to assess postoperative systemic inflammation.	Preoperatively and at 24 hours postoperatively.
Platelet-to-Lymphocyte Ratio (PLR)	The platelet-to-lymphocyte ratio (PLR) will be calculated as a marker of postoperative inflammation and its correlation with pain level and recovery quality.	Preoperatively and at 24 hours postoperatively.
Lymphocyte-to-Monocyte Ratio (LMR)	The lymphocyte-to-monocyte ratio (LMR) will be calculated to assess systemic immune response in relation to postoperative recovery.	Preoperatively and at 24 hours postoperatively.
Systemic Immune-Inflammation Index (SII)	The systemic immune-inflammation index (SII) will be calculated as platelet × neutrophil / lymphocyte, providing an integrated indicator of postoperative inflammatory and immune status.	Preoperatively and at 24 hours postoperatively.

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: İREM ATEŞ, Ataturk University; Principal Investigator: Nuray Uzun, Ataturk University

Publications and helpful links

General Publications

• Rettig TC, Verwijmeren L, Dijkstra IM, Boerma D, van de Garde EM, Noordzij PG. Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2016 Jun;263(6):1207-12. doi: 10.1097/SLA.0000000000001342.
• Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5.
• Jiao Y, Zhang X, Liu M, Sun Y, Ma Z, Gu X, Gu W, Zhu W. Systemic immune-inflammation index within the first postoperative hour as a predictor of severe postoperative complications in upper abdominal surgery: a retrospective single-center study. BMC Gastroenterol. 2022 Aug 27;22(1):403. doi: 10.1186/s12876-022-02482-9.
• Xu N, Zhang JX, Zhang JJ, Huang Z, Mao LC, Zhang ZY, Jin WD. The prognostic value of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) in colorectal cancer and colorectal anastomotic leakage patients: a retrospective study. BMC Surg. 2025 Feb 5;25(1):57. doi: 10.1186/s12893-024-02708-5.
• Yoon SH, Bae J, Yoon S, Na KJ, Lee HJ. Correlation Between Pain Intensity and Quality of Recovery After Video-Assisted Thoracic Surgery for Lung Cancer Resection. J Pain Res. 2023 Oct 2;16:3343-3352. doi: 10.2147/JPR.S426570. eCollection 2023.
• Mugabure Bujedo B. A clinical approach to neuraxial morphine for the treatment of postoperative pain. Pain Res Treat. 2012;2012:612145. doi: 10.1155/2012/612145. Epub 2012 Jul 2.
• Sibanyoni M, Biyase N, Motshabi Chakane P. The use of intrathecal morphine for acute postoperative pain in lower limb arthroplasty surgery: a survey of practice at an academic hospital. J Orthop Surg Res. 2022 Jun 21;17(1):323. doi: 10.1186/s13018-022-03215-0.
• Meng G, Chen W, Shi D, Mei B, Liu X. Superficial vs. deep serratus anterior plane block for analgesia in patients undergoing single-port video-assisted thoracoscopic surgery: A randomized prospective trial. J Clin Anesth. 2025 Sep;106:111950. doi: 10.1016/j.jclinane.2025.111950. Epub 2025 Jul 31.
• Liu Y, Liang F, Liu X, Shao X, Jiang N, Gan X. Dexmedetomidine Reduces Perioperative Opioid Consumption and Postoperative Pain Intensity in Neurosurgery: A Meta-analysis. J Neurosurg Anesthesiol. 2018 Apr;30(2):146-155. doi: 10.1097/ANA.0000000000000403.
• Liu Y, Zhao G, Zang X, Lu F, Liu P, Chen W. Effect of dexmedetomidine on opioid consumption and pain control after laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. Wideochir Inne Tech Maloinwazyjne. 2021 Sep;16(3):491-500. doi: 10.5114/wiitm.2021.104197. Epub 2021 Mar 8.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 2, 2026

Study Registration Dates

• First Submitted: September 19, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Analgesia; Intrathecal Morphine; Video-Assisted Thoracoscopic Surgery; Patient-Controlled Analgesia (PCA); Thoracic Surgery Pain Management
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Enzymes and Coenzymes; Population Characteristics; Demography; Coenzymes; Sphingolipid Activator Proteins; Dexmedetomidine; Population Groups; Saposins
• Other Study ID Numbers: B.30.2.ATA.0.01.00/614; 2025/2 (Atatürk University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study involves sensitive patient health information, and data confidentiality will be strictly maintained according to institutional ethical guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No