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Intrathecal Morphine for Recovery and Outcomes After 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07231926
Acronym
IMPROVE-VATS
Enrollment
52
Registered
2025-11-17
Start date
2025-12-01
Completion date
2026-06-02
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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

DRUGIntrathecal Morphine

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

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

DRUGDexmedetomidine

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

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery-15 (QoR-15) ScoreMeasured 24 hours after surgeryThe 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.

Secondary

MeasureTime frameDescription
Time to First Rescue OpioidWithin 24 hours postoperativelyDuration (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.
Postoperative Pain Scores (VAS)From postoperative hour 2 to hour 24.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.
Total Opioid Consumption24 hours postoperativelyCumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.
Intraoperative ComplicationsDuring surgeryOccurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.
Postoperative Adverse Effects24 hours postoperativelyIncidence of nausea, vomiting, pruritus, respiratory depression, or other opioid-related side effects during the first 24 hours postoperatively.
Serum Interleukin-6 (IL-6) LevelPreoperatively and at 24 hours postoperativelySerum IL-6 levels (pg/mL) will be measured to evaluate the systemic inflammatory response associated with surgical stress.
Neutrophil-to-Lymphocyte Ratio (NLR)Preoperatively and at 24 hours postoperativelyThe neutrophil-to-lymphocyte ratio (NLR) will be calculated to evaluate postoperative inflammatory status and its correlation with pain intensity and functional recovery.
Serum C-reactive Protein (CRP) LevelPreoperatively and at 24 hours postoperatively.Serum CRP levels (mg/L) will be measured to assess postoperative systemic inflammation.
Platelet-to-Lymphocyte Ratio (PLR)Preoperatively and at 24 hours postoperatively.The platelet-to-lymphocyte ratio (PLR) will be calculated as a marker of postoperative inflammation and its correlation with pain level and recovery quality.
Lymphocyte-to-Monocyte Ratio (LMR)Preoperatively and at 24 hours postoperatively.The lymphocyte-to-monocyte ratio (LMR) will be calculated to assess systemic immune response in relation to postoperative recovery.
Systemic Immune-Inflammation Index (SII)Preoperatively and at 24 hours postoperatively.The systemic immune-inflammation index (SII) will be calculated as platelet × neutrophil / lymphocyte, providing an integrated indicator of postoperative inflammatory and immune status.

Countries

Turkey (Türkiye)

Contacts

CONTACTİrem Ateş Associate Professor (Doçent Doktor)
driremates@hotmail.com+90 532 740 12 58
CONTACTMehmet Akif Yılmaz, assistant doctor
mehmetakifyilmaz025@gmail.com+90 534 653 35 39
PRINCIPAL_INVESTIGATORİREM ATEŞ

Ataturk University

PRINCIPAL_INVESTIGATORNuray Uzun

Ataturk University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026