Intrathecal Morphine for Recovery and Outcomes After VATS

NCT07231926 | Recruiting

• 2 other identifiers: B.30.2.ATA.0.01.00/6142025/2
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery

Keywords

Video-Assisted Thoracoscopic Surgery; Postoperative Analgesia; Intrathecal Morphine; Patient-Controlled Analgesia (PCA); Thoracic Surgery Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time to First Rescue Opioid

  Within 24 hours postoperatively

• Postoperative Pain Scores (VAS)

  From postoperative hour 2 to hour 24.

• Total Opioid Consumption

  24 hours postoperatively

• Intraoperative Complications

  During surgery

• Postoperative Adverse Effects

  24 hours postoperatively

Study Arms (2)

ITM + SAPB + Dex

EXPERIMENTAL

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; Procedure: Serratus Anterior Plane Block (SAPB) group; Drug: Dexmedetomidine

SAPB + Dex (No ITM)

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine

Interventions

Intrathecal Morphine DRUG

200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.

ITM + SAPB + Dex

Serratus Anterior Plane Block (SAPB) group PROCEDURE

Ultrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.

ITM + SAPB + Dex; SAPB + Dex (No ITM)

Dexmedetomidine DRUG

Loading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.

ITM + SAPB + Dex; SAPB + Dex (No ITM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28079737 BACKGROUND

• 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.

  PMID: 34691300 BACKGROUND

MeSH Terms

Interventions

Saposins; Population Groups; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Sphingolipid Activator Proteins; Coenzymes; Enzymes and Coenzymes; Demography; Population Characteristics; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• İREM ATEŞ

  Ataturk University

  PRINCIPAL INVESTIGATOR

• Nuray Uzun

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem Ateş Associate Professor (Doçent Doktor)

CONTACT

+90 532 740 12 58; driremates@hotmail.com

Mehmet Akif Yılmaz, assistant doctor

CONTACT

+90 534 653 35 39; mehmetakifyilmaz025@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative data collectors will be blinded to group allocation. The anesthesiologist performing the intervention will be aware of the allocation due to the nature of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator İrem Ateş

Model Details: Patients will be randomized into two groups in a 1:1 ratio: Group ITM + SAPB + Dexmedetomidine and Group SAPB + Dexmedetomidine.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)