NCT04737902

Brief Summary

The Erector Spinae Plane Block (ESPB) is an adequate alternative for pain management after video-assisted thoracoscopy surgery (VATS). The incidence of postoperative chronic neuropathic pain (CNP) and the quality of life (QoL) in patients with ESPB after VATS remain unknown. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and would report a good QoL up to three months after VATS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

January 30, 2021

Last Update Submit

January 30, 2021

Conditions

Postoperative PainVideo-assisted Thoracoscopic Surgery

Keywords

regional anesthesiapostoperative painvideo-assisted thoracoscopic surgeryerector spinae plane blockNeuropathic PainQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic neurophatic pain

    incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique

    3 month

Secondary Outcomes (2)

  • Postoperative pain

    24 hours

  • Quality of Life POP

    3 months POP

Study Arms (1)

VATS with ESPB

Study subjects underwent anaesthesia and VATS without a change in their routine care. At the end of the surgery, an erector spinae plane block was performed for acute pain control following our institutional protocol for perioperative care.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

Unilateral ESP block was performed between T3 and T7 levels depending on the thoracic surgical incision. The patient is placed in lateral decubitus position, under sterile conditions, a high frequency (6-15 MHz) linear-array transducer (Sonosite® Edge II, Bothell, USA) was placed in a longitudinal parasagittal orientation 2 cm from the posterior midline to visualise the tips of the transverse processes deep to the erector spinae muscle (ESM). A 21 G, 50 mm or 100 mm needle (Pajunk UniPlex NanoLine; Germany) was advanced in-plane with the ultrasound beam. The needle tip was directed to the plane between the transverse process and the posterior fascia of the ESM. Correct needle tip location was confirmed by ultrasound visualisation of linear fluid spread in the fascial plane. The injection of 0.5 to 1 ml of bupivacaine was 0.5% with epinephrine 5 µg/ml; then, a total of 20-30 ml of the same local anaesthetic was administered.

VATS with ESPB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • patients who underwent VATS and required at least one day of hospital stay after surgery

You may not qualify if:

  • patients with mental or physical limitation to answer the questionnaires.
  • patients who required mechanical ventilation.
  • patients who required surgery conversion to thoracotomy.
  • patients who declined consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario

Bogota, Cundinamarca, 11001000, Colombia

Location

Related Publications (2)

  • Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.

    PMID: 28248713BACKGROUND

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeNeuralgia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Lorena Díaz-Bohada, MD, MSc

    Hospital Universitario San Ignacio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

January 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)