Paravertebral Block Versus Thoracic Epidural Analgesia

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Lung Cancer
• Intervention / Treatment: Drug: Thoracic epidural; Drug: Paravertebral block

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic epidural analgesia; Standard thoracic epidurals preoperatively at the dag of surgery.	Drug: Thoracic 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.
Experimental: Paravertebral block; Paravertebral block inserted at the end of the operation by the surgeons	Drug: Paravertebral 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital length of stay in days	until discharge from hospital (max 1 month)

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Investigators: Study Director: Alexander Wahba, md phd, St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Epidural analgesia; Pneumonectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2017/2424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No