Intrathecal Morphine for Recovery and Outcomes After VATS

NCT ID: NCT07231926

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-06-02

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Management in Video-Assisted Thoracoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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ITM + SAPB + Dex

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.

Group Type EXPERIMENTAL

Intrathecal Morphine

Intervention Type DRUG

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

Serratus Anterior Plane Block (SAPB) group

Intervention Type PROCEDURE

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

Dexmedetomidine

Intervention Type DRUG

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

SAPB + Dex (No ITM)

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.

Group Type ACTIVE_COMPARATOR

Serratus Anterior Plane Block (SAPB) group

Intervention Type PROCEDURE

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

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Intrathecal Morphine

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

Intervention Type DRUG

Serratus Anterior Plane Block (SAPB) group

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

Intervention Type PROCEDURE

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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irem ateş

Principal Investigator İrem Ateş

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İREM ATEŞ

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Nuray Uzun

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İrem Ateş Associate Professor (Doçent Doktor)

Role: CONTACT

+90 532 740 12 58

Mehmet Akif Yılmaz, assistant doctor

Role: CONTACT

+90 534 653 35 39

Facility Contacts

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Mehmet Akif Yılmaz, assistant doctor

Role: primary

+90 534 653 35 39

Mehmet Akif Yilmaz

Role: primary

05346533539

References

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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.

Reference Type BACKGROUND
PMID: 36030214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39910526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26135695 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32316949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37808464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23002426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35729586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40749388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28079737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34691300 (View on PubMed)

Other Identifiers

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2025/2

Identifier Type: OTHER

Identifier Source: secondary_id

B.30.2.ATA.0.01.00/614

Identifier Type: -

Identifier Source: org_study_id

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