NCT07002788

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive alternative to thoracotomy that emerged in the early 1990s, aiming to reduce surgical stress and postoperative pain. While VATS generally results in less pain than thoracotomy, patients may still experience significant discomfort. Effective pain control remains crucial in VATS to minimize postoperative complications, especially pulmonary and cardiac events, which can arise from inadequate ventilation and impaired sputum clearance due to pain. Various strategies have been developed to manage postoperative pain, with multimodal approaches-combining regional or peripheral blocks with systemic analgesics such as NSAIDs and adjuvants-now considered standard. Among regional techniques, serratus anterior plane (SAP) block and thoracic paravertebral block (PVB) are commonly used. SAP block targets the thoracodorsal, long thoracic, and T2-T9 spinal nerves between the latissimus dorsi and serratus anterior muscles, providing effective anterolateral chest wall analgesia. PVB targets intercostal nerves within the paravertebral space and has shown superior pain control and improved lung function compared to systemic opioids or intrapleural local anesthetics. At our center, both SAP and PVB are routinely used for postoperative analgesia in VATS procedures for patients with lung masses. Pain levels will be assessed using the Visual Analog Scale (VAS), a reliable tool for evaluating both acute and chronic pain, unaffected by age or gender. This study aims to compare the effectiveness of SAP and PVB blocks in terms of postoperative pain, opioid requirements, and block-related complications in patients undergoing VATS under general anesthesia. The research is observational and will not alter routine clinical practices.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

June 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

March 16, 2025

Last Update Submit

May 26, 2025

Conditions

Keywords

paravertebral blockserratus anterior plane blocklung cancervideo-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Scores (VAS)

    Pain assessment will be performed by Res. Asst. Dr. Rabia Çakmak at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Pain scores will be evaluated at rest and during coughing using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.

    Within the first 24 hours after surgery

  • Total Postoperative Morphine Consumption

    Total morphine consumption in the first 24 hours after surgery will be recorded by the patient-controlled analgesia (PCA) device.

    Within the first 24 hours after surgery

Secondary Outcomes (1)

  • Total Rescue Analgesic Use

    Within the first 24 hours after surgery

Study Arms (2)

Paravertebral block

ACTIVE COMPARATOR

Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography.

Drug: BupivacaineDrug: MorphineDrug: ParacetamolDrug: Diklofenak Sodyum

serratus anterior plane block

ACTIVE COMPARATOR

In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound.

Drug: BupivacaineDrug: MorphineDrug: ParacetamolDrug: Diklofenak Sodyum

Interventions

Used for regional anesthesia during VATS procedure (e.g., paravertebral or serratus anterior plane block)

Also known as: Bupivakain
Paravertebral blockserratus anterior plane block

Used for postoperative pain control via PCA device.

Also known as: morfin
Paravertebral blockserratus anterior plane block

Used as part of postoperative multimodal analgesia

Also known as: Acetaminophen
Paravertebral blockserratus anterior plane block

Administered for postoperative pain management

Also known as: NSAID
Paravertebral blockserratus anterior plane block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18-64 who gave consent to participate in the study
  • Patients between the ages of 65-90 who received a score of 24 or more from the mini mental test and gave consent to participate in the study
  • ASA 1-3 patients

You may not qualify if:

  • Those with neuropathy,
  • Those with renal failure,
  • Those with liver failure,
  • Those with coagulopathy,
  • Those with local anesthetic allergy,
  • Those with infection in the area where the procedure will be performed,
  • Those with congenital muscle absence in the area where the block will be performed
  • Patients who did not give consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Üniversitesi

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

    PMID: 11733293BACKGROUND
  • Gagliese L, Katz J. Age differences in postoperative pain are scale dependent: a comparison of measures of pain intensity and quality in younger and older surgical patients. Pain. 2003 May;103(1-2):11-20. doi: 10.1016/s0304-3959(02)00327-5.

    PMID: 12749954BACKGROUND
  • Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.

    PMID: 32734596BACKGROUND
  • Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.

    PMID: 34739134BACKGROUND

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

BupivacaineMorphineAcetaminophenAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Officials

  • murat izgi

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 16, 2025

First Posted

June 4, 2025

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

June 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Only results

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
2026-2030
Access Criteria
Individual participant data and supporting documents will be made publicly available without restriction

Locations