NCT04964401

Brief Summary

Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB), which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and randomized controlled prospective studies with ESPB are increasing. In this study, it is planned to compare the effects of US-guided TPVB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable postoperative-pain

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

Study Start

First participant enrolled

April 13, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

July 13, 2021

Last Update Submit

September 22, 2021

Conditions

Postoperative PainVideo-Assisted Thoracoscopic SurgeryThoracic Paravertebral BlockErector Spinae Plane BlockAcute PainChronic Pain

Keywords

Chronic painErector spinae plane blockThoracic paravertebral blockAcute pain

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.

    24 hours after surgery

Secondary Outcomes (1)

  • Chronic pain

    First and 3th month

Study Arms (2)

Thoracic Paravertebral Block

ACTIVE COMPARATOR

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the thoracic 5 spinous process, the US-compatible needle will be advanced to the paravertebral area with in-plane technique, and 20 ml of 0.25% bupivacaine hydrochloride will be injected into this area.

Procedure: Thoracic paravertebral block vs Erector spinae plane block

Erector spinae plane block

ACTIVE COMPARATOR

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.

Procedure: Thoracic paravertebral block vs Erector spinae plane block

Interventions

Thoracic paravertebral block vs Erector spinae plane blockPROCEDURE

Thoracic paravertebral block and erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.

Erector spinae plane blockThoracic Paravertebral Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-30 kg/m2
  • Patients undergoing elective video assiste thoracoscopic surgery

You may not qualify if:

  • Advanced cancer
  • History of chronic analgesic therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Patients with bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAcute PainChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Musa Zengin, MD

    Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 16, 2021

Study Start

April 13, 2021

Primary Completion

September 13, 2021

Study Completion

September 23, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)