ESP Block, CNP and QoL After VATS

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04737902
• Other study ID #: FMCIE-0043-19
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: January 2021
• Source: Hospital Universitario San Ignacio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Video-assisted Thoracoscopic Surgery

Intervention

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.

Locations

Country	Name	City	State
Colombia	Hospital Universitario	Bogota	Cundinamarca

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario San Ignacio

Country where clinical trial is conducted

Colombia, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain	pain control at PACU, 12 and 24 hours POP	24 hours
Secondary	Quality of Life POP	Quality of Life by EQ-5D	3 months POP