Paravertebral Block Versus Thoracic Epidural Analgesia

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025606
• Other study ID #: 2017/2424
• Status: Completed
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in minutes total time at the operating ward		1 hour
Primary	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	Hospital length of stay in days		until discharge from hospital (max 1 month)