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Paravertebral Block Versus Thoracic Epidural Analgesia

Primary Purpose

Lung Cancer, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Thoracic epidural
Paravertebral block
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Epidural analgesia, Pneumonectomy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thoracic epidural analgesia

Paravertebral block

Arm Description

Standard thoracic epidurals preoperatively at the dag of surgery.

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

Outcomes

Primary Outcome Measures

Time in minutes total time at the operating ward
Pain intensity during hospitalization: Numerical Rating Scale (NRS)
using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation

Secondary Outcome Measures

Hospital length of stay in days

Full Information

First Posted
June 12, 2019
Last Updated
September 20, 2022
Sponsor
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04025606
Brief Title
Paravertebral Block Versus Thoracic Epidural Analgesia
Official Title
Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Postoperative Pain
Keywords
Epidural analgesia, Pneumonectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic epidural analgesia
Arm Type
Active Comparator
Arm Description
Standard thoracic epidurals preoperatively at the dag of surgery.
Arm Title
Paravertebral block
Arm Type
Experimental
Arm Description
Paravertebral block inserted at the end of the operation by the surgeons
Intervention Type
Drug
Intervention Name(s)
Thoracic epidural
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paravertebral block
Intervention Description
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 Outcome Measure Information:
Title
Time in minutes total time at the operating ward
Time Frame
1 hour
Title
Pain intensity during hospitalization: Numerical Rating Scale (NRS)
Description
using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation
Time Frame
Up to 12 months after surgery
Secondary Outcome Measure Information:
Title
Hospital length of stay in days
Time Frame
until discharge from hospital (max 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Erik Berg Krogstad, md
Phone
0047 95166543
Email
larserkr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Wahba, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Erik Berg Krogstad, md
Email
larserkr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Paravertebral Block Versus Thoracic Epidural Analgesia

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