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CompletedNCT04025606Updated Jan 3, 2024

Paravertebral Block Versus Thoracic Epidural Analgesia

An interventional study of Thoracic epidural and Paravertebral block in Lung Cancer and Postoperative Pain, sponsored by St. Olavs Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by St. Olavs Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer
  • Postoperative Pain

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Keywords

  • Epidural analgesia
  • Pneumonectomy
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 94 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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, 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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Active comparator
    Thoracic epidural analgesia

    Standard thoracic epidurals preoperatively at the dag of surgery.

    Drug: Thoracic epidural

  • Experimental
    Paravertebral block

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

    Drug: Paravertebral block

Interventions

  • DrugThoracic epidural

    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.

  • DrugParavertebral block

    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.

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What researchers measure

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)

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

    Time frame: Up to 12 months after surgery

Secondary outcomes

  1. Hospital length of stay in days

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

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Study locations

1 site
  • St Olavs Hospital
    Trondheim, Norway
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04025606
Lead sponsor
St. Olavs Hospital
Responsible party
Sponsor
First posted
Jul 19, 2019
Start date
Jun 24, 2019
Primary completion
Dec 1, 2022
Completion
Dec 1, 2022
Last update
Jan 3, 2024

Study contacts

Alexander Wahba, md phd
study director · St. Olavs Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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