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Recruiting NCT07231926

Intrathecal Morphine for Recovery and Outcomes After VATS

No phase Interventional Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrathecal Morphine, Serratus Anterior Plane Block (SAPB) group, Dexmedetomidine.
Who it may be relevant to
Registry conditions: Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Quality of Recovery-15 (QoR-15) Score [Time frame: Measured 24 hours after surgery]
Secondary outcome measures (11)
  • Time to First Rescue Opioid [Time frame: Within 24 hours postoperatively]
  • Postoperative Pain Scores (VAS) [Time frame: From postoperative hour 2 to hour 24.]
  • Total Opioid Consumption [Time frame: 24 hours postoperatively]
  • Intraoperative Complications [Time frame: During surgery]
  • Postoperative Adverse Effects [Time frame: 24 hours postoperatively]
  • Serum Interleukin-6 (IL-6) Level [Time frame: Preoperatively and at 24 hours postoperatively]
  • Neutrophil-to-Lymphocyte Ratio (NLR) [Time frame: Preoperatively and at 24 hours postoperatively]
  • Serum C-reactive Protein (CRP) Level [Time frame: Preoperatively and at 24 hours postoperatively.]
  • Platelet-to-Lymphocyte Ratio (PLR) [Time frame: Preoperatively and at 24 hours postoperatively.]
  • Lymphocyte-to-Monocyte Ratio (LMR) [Time frame: Preoperatively and at 24 hours postoperatively.]
  • Systemic Immune-Inflammation Index (SII) [Time frame: Preoperatively and at 24 hours postoperatively.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 2 centers
  • Ataturk University — Erzurum
  • Ataturk University — Erzurum

Publications

  • 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. PMID 36030214
  • 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. PMID 39910526
  • 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. PMID 26135695
  • 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. PMID 32316949
  • 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. PMID 37808464
  • 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. PMID 23002426
  • 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. PMID 35729586
  • 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. PMID 40749388

Identifiers

NCT: NCT07231926 · B.30.2.ATA.0.01.00/614 · 2025/2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗