ESP Block, CNP and QoL After VATS

NCT ID: NCT04737902

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-04-30

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.

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.

Conditions

Postoperative Pain; Video-assisted Thoracoscopic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Erector spinae plane block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario San Ignacio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorena Díaz-Bohada, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario San Ignacio

Locations

Hospital Universitario

Bogota, Cundinamarca, Colombia

Countries

Colombia

References

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.

Reference Type: BACKGROUND

PMID: 28248713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27501016 (View on PubMed)

Other Identifiers

FMCIE-0043-19

Identifier Type: -

Identifier Source: org_study_id