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Postoperative Pain Management in Video-Assisted Thoracoscopic SurgeryIMPROVE-VATSNCT07231926

Intrathecal Morphine for Recovery and Outcomes After VATS

A study testing Intrathecal Morphine, Serratus Anterior Plane Block (SAPB) group and Dexmedetomidine in people with Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery, run by Ataturk University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Intrathecal Morphine, Serratus Anterior Plane Block (SAPB) group and Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Dec 2025to 3 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Ataturk University

    Erzurum, 25000

  • Ataturk University

    Erzurum, 25240

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Intrathecal Morphine, Serratus Anterior Plane Block (SAPB) group, Dexmedetomidine
Keywords
Video-Assisted Thoracoscopic Surgery, Postoperative Analgesia, Intrathecal Morphine, Patient-Controlled Analgesia (PCA), Thoracic Surgery Pain Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal MorphineDrug

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

  • Serratus Anterior Plane Block (SAPB) groupProcedure or surgery

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

  • DexmedetomidineDrug

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

Study groups in NCT07231926
Study groupRoleWhat they receive
ITM + SAPB + DexExperimentalBefore 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.
Receives: Drug: Intrathecal Morphine; Procedure: Serratus Anterior Plane Block (SAPB) group; Drug: Dexmedetomidine
SAPB + Dex (No ITM)Active comparatorSame 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.
Receives: Procedure: Serratus Anterior Plane Block (SAPB) group; Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured 24 hours after surgery

Secondary outcomes (11)
  1. 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.

    Measured: Within 24 hours postoperatively

  2. 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.

    Measured: From postoperative hour 2 to hour 24.

  3. Total Opioid Consumption

    Cumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.

    Measured: 24 hours postoperatively

  4. Intraoperative Complications

    Occurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.

    Measured: During surgery

  5. Postoperative Adverse Effects

    Incidence of nausea, vomiting, pruritus, respiratory depression, or other opioid-related side effects during the first 24 hours postoperatively.

    Measured: 24 hours postoperatively

  6. 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.

    Measured: Preoperatively and at 24 hours postoperatively

  7. 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.

    Measured: Preoperatively and at 24 hours postoperatively

  8. Serum C-reactive Protein (CRP) Level

    Serum CRP levels (mg/L) will be measured to assess postoperative systemic inflammation.

    Measured: Preoperatively and at 24 hours postoperatively.

  9. 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.

    Measured: Preoperatively and at 24 hours postoperatively.

  10. Lymphocyte-to-Monocyte Ratio (LMR)

    The lymphocyte-to-monocyte ratio (LMR) will be calculated to assess systemic immune response in relation to postoperative recovery.

    Measured: Preoperatively and at 24 hours postoperatively.

  11. 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.

    Measured: Preoperatively and at 24 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion2 Jul 2026
  4. Study completion3 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized into two groups in a 1:1 ratio: Group ITM + SAPB + Dexmedetomidine and Group SAPB + Dexmedetomidine.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07231926
Sponsor's protocol ID
B.30.2.ATA.0.01.00/614
Other IDs
2025/2
Acronym
IMPROVE-VATS
Status last verified
Sep 2026
First submitted
19 Sep 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40749388
  • 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.

    PubMed 28079737
  • 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.

    PubMed 34691300

Questions about this trial

What is this clinical trial studying?

A study testing Intrathecal Morphine, Serratus Anterior Plane Block (SAPB) group and Dexmedetomidine in people with Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery, run by Ataturk University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 (QoR-15) Score (time frame: Measured 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07231926, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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