Effects of Erector Spina Plane Block and Paravertebral Block on Early Postoperative Pulmonary Function Test Parameters

NCT06584201 | Recruiting

• 1 other identifier: E-96317027-514.10-222446069
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Function Loss; Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Effectiveness on respiratory functions

  All adult participants undergoing video-assisted thoracoscopic surgery (VATS) will have a preoperative pulmonary function test (PFT) conducted by an anesthetist using a portable device within the Thoracic Surgery service. The tests will be evaluated using a color-coded compliance chart: Red (Non-compliant), Yellow (Moderately compliant), Green (Compliant). The test will be repeated until compliance is achieved, with Yellow and Green results recorded. Postoperatively, PFTs will be repeated at 0, 6, 24 hours, and before discharge. The specific pulmonary function tests assessed include Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), Peak Expiratory Flow (PEF), Forced Expiratory Flow at 25-75% (FEF25-75), and the FEV1/FVC ratio. Each test will be reported as separate outcome measures. Respiratory function tests will be conducted 24 hours before surgery and then postoperatively at the specified intervals.

  Respiratory function tests will be performed 24 hours before surgery and at 0, 6, and 24 hours postoperatively, as well as before discharge. The average length of stay is 2 days, and for extended stays, the 48-hour data will be used as a baseline.

Secondary Outcomes (1)

• Effect on total narcotic analgesic consumption

  Total dose administered at the end of 24 hours of the intravenous PCA device inserted simultaneously after surgery

Other Outcomes (1)

• Effectiveness on pain scores

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

Study Arms (2)

ESP Group

Patients in this group will receive the Erector Spinae Plane Block (ESP) as a method of postoperative pain management.

Procedure: Erector Spinae Plane Block (ESP)

Paravertebral Group

Patients in this group will receive the Paravertebral Block (PVB) for postoperative pain relief.

Procedure: Paravertebral Block (PVB)

Interventions

Erector Spinae Plane Block (ESP) PROCEDURE

The ESP block will be administered before the VATS procedure, aiming to manage postoperative pain and minimize the impact on early lung function test (SFT) parameters. The block will be performed using standard techniques under ultrasound guidance to ensure accurate placement.

ESP Group

Paravertebral Block (PVB) PROCEDURE

The PVB will be administered prior to the VATS procedure, with the objective of managing postoperative pain and assessing its impact on early postoperative lung function (SFT) parameters. This block will also be performed using standard techniques and ultrasound guidance for precision.

Paravertebral Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 18-65 who will undergo video-assisted thorascopic surgery

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 30kg/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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Çam Ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

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: 24980146 RESULT

• 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: 16181921 RESULT

• 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: 33667460 RESULT

• 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: 34277232 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

ÖZAL ADIYEKE

CONTACT

00905377398652; ozaladiyeke@gmail.com

ALİ KAHVECİOĞLU

CONTACT

00905549134317; ali.kahveci92@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• 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, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

TU (1)