ESP Block, CNP and QoL After VATS

Erector Spinae Plane (ESP) Block, Incidence of Chronic Neuropathic Pain (CNP) and Quality of Life (QoL) After VATS. An Observational Study.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Video-assisted Thoracoscopic Surgery
• Intervention / Treatment: Procedure: Erector spinae plane block

Detailed Description

We, therefore, performed this prospective observational study. The a priori primary outcome was incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique. The secondary outcome was to describe pain control at PACU, 12 and 24 hours POP and QoL reported up to three months after surgery. We hypothesised that patients with ESPB would have a low incidence of acute and CNP and report a good QoL.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia, 11001000
      • Hospital Universitario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	pain control at PACU, 12 and 24 hours POP	24 hours
Quality of Life POP	Quality of Life by EQ-5D	3 months POP

Collaborators and Investigators

• Sponsor: Hospital Universitario San Ignacio
• Investigators: Principal Investigator: Lorena Díaz-Bohada, MD, MSc, Hospital Universitario San Ignacio

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; postoperative pain; Neuropathic Pain; regional anesthesia; video-assisted thoracoscopic surgery; erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FMCIE-0043-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No