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NCT Number: NCT04025606

Paravertebral Block Versus Thoracic Epidural Analgesia

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

, Per- and postoperative

  • conversion from VATS to thoractomy.
  • unsuccessful admission of thoracic epidural analgesia
  • unsuccessful admission of paravertebral block
  • postoperative respiratory treatment
  • postoperative delirium Patients who for various reasons are not able to self-report pain after surgery.

Patients who wish to withdraw from the study

Treatment and study plan

Thoracic epidural

Drug

Standard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours.

paravertebral block

Drug

Paravertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery.

Primary outcomes

  1. Time in minutes total time at the operating ward

    Time frame: 1 hour

  2. 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

  1. Hospital length of stay in days

    Time frame: until discharge from hospital (max 1 month)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2019
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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