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Clinical Trials/NCT04025606
NCT04025606
Completed
Not Applicable

Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery

St. Olavs Hospital1 site in 1 country94 target enrollmentJune 24, 2019

Overview

Phase
Not Applicable
Intervention
Thoracic epidural
Conditions
Lung Cancer
Sponsor
St. Olavs Hospital
Enrollment
94
Locations
1
Primary Endpoint
Time in minutes total time at the operating ward
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.

Registry
clinicaltrials.gov
Start Date
June 24, 2019
End Date
December 1, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy
  • Exclusion Criteria, preoperative:
  • Patients who do not wish to participate
  • Patients with:
  • suspicion of ingrowth in the thoracic wall.
  • marginal lung function.
  • kidney failure.
  • chronic pains and/ or daily use of opioids.
  • cognitive, visual and / or linguistic dysfunction.
  • allergies to drugs used in the paravertebral block or the thoracic epidural analgesia.

Exclusion Criteria

  • Not provided

Arms & Interventions

Thoracic epidural analgesia

Standard thoracic epidurals preoperatively at the dag of surgery.

Intervention: Thoracic epidural

Paravertebral block

Paravertebral block inserted at the end of the operation by the surgeons

Intervention: Paravertebral block

Outcomes

Primary Outcomes

Time in minutes total time at the operating ward

Time Frame: 1 hour

Pain intensity during hospitalization: Numerical Rating Scale (NRS)

Time Frame: Up to 12 months after surgery

using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation

Secondary Outcomes

  • Hospital length of stay in days(until discharge from hospital (max 1 month))

Study Sites (1)

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