NCT06584201

Brief Summary

The pain experienced by participants after minimally invasive chest surgery (VATS) can make it difficult for them to take deep breaths, which can lead to problems with lung function. This can cause serious problems such as lung collapse, low oxygen levels, and infections, making recovery longer and more difficult. Managing pain well after surgery is important to prevent these problems and speed up recovery. In this study, we aimed to compare two pain relief methods, Erector Spinae Plane Block (ESP) and Paravertebral Block (PVB), in participants who underwent VATS. We will look at which method causes the smallest change in lung function before and after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 9, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 14, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 9, 2024

Last Update Submit

September 11, 2026

Conditions

Opioid UseRespiratory Function LossPain, Postoperative

Outcome Measures

Primary Outcomes (4)

  • Change in Forced Vital Capacity(FVC)

    Forced Vital Capacity (FVC) will be assessed using pulmonary function testing and reported in liters (L).

    Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  • Change in Forced Expiratory Volume in 1 Second (FEV1)

    Forced Expiratory Volume in 1 second (FEV1) will be assessed using pulmonary function testing and reported in liters (L).

    Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  • Change in Peak Expiratory Flow (PEF)

    Peak Expiratory Flow (PEF) will be assessed using pulmonary function testing and reported in liters per minute (L/min).

    Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

  • Change in FEV1/FVC Ratio

    The FEV1/FVC ratio will be assessed using pulmonary function testing and reported as a percentage (%).

    Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 12 hours postoperatively, as well as before hospital discharge.

Secondary Outcomes (4)

  • Total Postoperative Morphine Consumption

    From the end of surgery to 24 hours postoperatively.

  • Number of Postoperative Morphine Boluses

    From the end of surgery to 24 hours postoperatively.

  • Postoperative Pain at Rest

    0, 1, 4, 6, 12, and 24 hours after surgery.

  • Postoperative Pain During Movement

    0, 1, 4, 6, 12, and 24 hours after surgery.

Study Arms (2)

ESP Group

EXPERIMENTAL

Patients in this group received the erector spinae plane block (ESPB) as a method of postoperative pain management.

Procedure: Erector Spinae Plane Block (ESPB)

Paravertebral Group

ACTIVE COMPARATOR

Patients in this group received the paravertebral block (PVB) before the VATS procedure under ultrasound guidance for postoperative analgesia.

Procedure: Paravertebral Block (PVB)

Interventions

Paravertebral Block (PVB)PROCEDURE

The paravertebral block (PVB) was performed before the VATS procedure under ultrasound guidance for postoperative analgesia. The block was performed using a standardized technique.

Paravertebral Group
Erector Spinae Plane Block (ESPB)PROCEDURE

The erector spinae plane block (ESPB) was performed before the VATS procedure under ultrasound guidance for postoperative analgesia. The block was performed using a standardized technique, with local anesthetic administered into the erector spinae plane.

ESP Group

Eligibility Criteria

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

You may qualify if:

  • Both genders
  • Being between the ages of 18 and 65
  • ASA(American Society of Anesthesiologists) I-II-III
  • Body mass index between 19 and 35kg/m2
  • Providing voluntary participation
  • Must be fully oriented and able to cooperate

You may not qualify if:

  • ASA(American Society of Anesthesiologists) IV-V
  • Patients who refuse to participate in the study
  • Patients under 18 years of age
  • Patients over 65 years of age
  • Presence of active infection in the area to be treated
  • Chronic pain and constant analgesic use
  • Patients with coagulation disorders
  • Patients who cannot cooperate with postoperative pain follow-ups
  • Cases taken urgently
  • Patients with severe renal failure (creatinine\>2mg/dl)
  • Severe impairment of heart function (New York Heart Association Functional Classification III-IV)
  • Patients with known allergies to bupivacaine and other amide local anesthetic substances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Çam Ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Matyal R, Montealegre-Gallegos M, Shnider M, Owais K, Sakamuri S, Shakil O, Shah V, Pawlowski J, Gangadharan S, Hess P. Preemptive ultrasound-guided paravertebral block and immediate postoperative lung function. Gen Thorac Cardiovasc Surg. 2015 Jan;63(1):43-8. doi: 10.1007/s11748-014-0442-6. Epub 2014 Jul 1.

    PMID: 24980146RESULT

  • Detterbeck FC. Efficacy of methods of intercostal nerve blockade for pain relief after thoracotomy. Ann Thorac Surg. 2005 Oct;80(4):1550-9. doi: 10.1016/j.athoracsur.2004.11.051.

    PMID: 16181921RESULT

  • Gao W, Yang XL, Hu JC, Gu H, Wu XN, Hu SS, Wang S, Chai XQ, Wang D. Continuous Serratus Anterior Plane Block Improved Early Pulmonary Function After Lung Cancer Surgical Procedure. Ann Thorac Surg. 2022 Feb;113(2):436-443. doi: 10.1016/j.athoracsur.2021.02.032. Epub 2021 Mar 2.

    PMID: 33667460RESULT

  • Zengin M, Baldemir R, Ulger G, Sazak H, Alagoz A. Postoperative Analgesic Efficacy of Thoracic Paravertebral Block and Erector Spinae Plane Block Combination in Video-Assisted Thoracic Surgery. Cureus. 2021 Jun 12;13(6):e15614. doi: 10.7759/cureus.15614. eCollection 2021 Jun.

    PMID: 34277232RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

August 9, 2024

First Posted

September 4, 2024

Study Start

November 1, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

September 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)