Paravertebral Block Versus Thoracic Epidural Analgesia

NCT04025606 | Completed

• 1 other identifier: 2017/2424
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Postoperative Pain

Keywords

Epidural analgesia; Pneumonectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Hospital length of stay in days

  until discharge from hospital (max 1 month)

Study Arms (2)

Thoracic epidural analgesia

ACTIVE COMPARATOR

Standard thoracic epidurals preoperatively at the dag of surgery.

Drug: Thoracic epidural

Paravertebral block

EXPERIMENTAL

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

Drug: Paravertebral block

Interventions

Thoracic epidural DRUG

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.

Thoracic epidural analgesia

Paravertebral block DRUG

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.

Paravertebral block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Interventions

Tea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alexander Wahba, md phd

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: July 19, 2019
• Study Start: June 24, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)