Paravertebral Block Versus Thoracic Epidural Analgesia

Not Applicable

Completed

• Conditions: Postoperative Pain; Lung Cancer
• Interventions: Drug: Paravertebral block; Drug: Thoracic epidural

• Registration Number: NCT04025606
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study Start: 2019-06-24
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral block	Paravertebral block	Paravertebral block inserted at the end of the operation by the surgeons
Thoracic epidural analgesia	Thoracic epidural	Standard thoracic epidurals preoperatively at the dag of surgery.

Primary Outcome Measures

Name	Time	Method
Time in minutes total time at the operating ward	1 hour
Pain intensity during hospitalization: Numerical Rating Scale (NRS)	Up to 12 months after surgery	using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay in days	until discharge from hospital (max 1 month)

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway