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Paravertebral Block Versus Thoracic Epidural Analgesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04025606
Enrollment
94
Registered
2019-07-19
Start date
2019-06-24
Completion date
2022-12-01
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Postoperative Pain

Keywords

Epidural analgesia, Pneumonectomy

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.

Interventions

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.

Sponsors

St. Olavs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time in minutes total time at the operating ward1 hour
Pain intensity during hospitalization: Numerical Rating Scale (NRS)Up to 12 months after surgeryusing the Numerical Rating Scale (NRS) in predetermined time intervals after the operation

Secondary

MeasureTime frame
Hospital length of stay in daysuntil discharge from hospital (max 1 month)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026