Paravertebral Block Versus Thoracic Epidural Analgesia

NCT ID: NCT04025606

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2022-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thoracic epidural analgesia

Standard thoracic epidurals preoperatively at the dag of surgery.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural

Intervention Type: 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.

Paravertebral block

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

Group Type: EXPERIMENTAL

Paravertebral block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Wahba, md phd

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2017/2424

Identifier Type: -

Identifier Source: org_study_id