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ESP Block, CNP and QoL After VATS

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ClinicalTrials.gov Identifier: NCT04737902
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario San Ignacio

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Pain Video-assisted Thoracoscopic Surgery 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 Design
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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Erector Spinae Plane (ESP) Block, Incidence of Chronic Neuropathic Pain (CNP) and Quality of Life (QoL) After VATS. An Observational Study.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of chronic neurophatic pain [ Time Frame: 3 month ]
    incidence of CNP three months postoperatively (POP) in patients undergoing VATS surgery with ESPB as the regional anaesthesia technique


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours ]
    pain control at PACU, 12 and 24 hours POP

  2. Quality of Life POP [ Time Frame: 3 months POP ]
    Quality of Life by EQ-5D


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737902


Locations
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Colombia
Hospital Universitario
Bogota, Cundinamarca, Colombia, 11001000
Sponsors and Collaborators
Hospital Universitario San Ignacio
Investigators
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Principal Investigator: Lorena Díaz-Bohada, MD, MSc Hospital Universitario San Ignacio
More Information
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Publications:

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Responsible Party: Hospital Universitario San Ignacio
ClinicalTrials.gov Identifier: NCT04737902    
Other Study ID Numbers: FMCIE-0043-19
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitario San Ignacio:
regional anesthesia
postoperative pain
video-assisted thoracoscopic surgery
 erector spinae plane block
Neuropathic Pain
Quality of Life
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations