Intrathecal morphine
Drug200 µg morphine sulfate, single-dose via L3-L4, 27G Sprotte spinal needle, prior to induction.
Recruiting
NCT Number: NCT07231926
Intrathecal Morphine for Recovery and Outcomes After VATS
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Ataturk University, Erzurum, Turkey (Türkiye)
Loading trial locations.
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Serratus Anterior Plane Block (SAPB) group
ProcedureUltrasound-guided unilateral SAPB at end of surgery with 30 mL 0.25% bupivacaine.
Dexmedetomidine
DrugLoading dose 0.5 µg/kg over 15 minutes, then 0.5 µg/kg/h continuous infusion intraoperatively.
Primary outcomes
-
Quality of Recovery-15 (QoR-15) Score
Time frame: Measured 24 hours after surgery
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.
Secondary outcomes
-
Time to First Rescue Opioid
Time frame: Within 24 hours postoperatively
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.
-
Postoperative Pain Scores (VAS)
Time frame: 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 Consumption
Time frame: 24 hours postoperatively
Cumulative opioid consumption (including PCA tramadol, subcutaneous morphine, and rescue IV tramadol) within 24 hours postoperatively, reported in mg.
-
Intraoperative Complications
Time frame: During surgery
Occurrence of bradycardia, hypotension, or other anesthesia-related intraoperative adverse events.
-
Postoperative Adverse Effects
Time frame: 24 hours postoperatively
Incidence of nausea, vomiting, pruritus, respiratory depression, or other opioid-related side effects during the first 24 hours postoperatively.
-
Serum Interleukin-6 (IL-6) Level
Time frame: Preoperatively and at 24 hours postoperatively
Serum IL-6 levels (pg/mL) will be measured to evaluate the systemic inflammatory response associated with surgical stress.
-
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperatively and at 24 hours postoperatively
The 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) Level
Time frame: Preoperatively and at 24 hours postoperatively.
Serum CRP levels (mg/L) will be measured to assess postoperative systemic inflammation.
-
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Mehmet Akif Yılmaz, assistant doctor
CONTACT
İrem Ateş Associate Professor (Doçent Doktor)
CONTACT
Sponsors and collaborators
Lead sponsor
Ataturk University
Other
Registry information
Official study 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
Acronym: IMPROVE-VATS
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 17, 2025
- Registry last updated
- Feb 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.