NCT03677856: TOPIC-2

The Effectiveness of ThOracic Epidural and Paravertebral Blockade In Reducing Chronic Post- Thoracotomy Pain: 2

Status unknown NA Last updated 26 September 2019

What this trial tests

NA trial testing Paravertebral blockade in Anesthesia in 1,026 participants. Status unknown.

Timeline

8 January 2019

Primary endpoint
8 January 2022

1 October 2022

Quick facts

Lead sponsor	University of Birmingham
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,026
Start date	8 January 2019
Primary completion	8 January 2022
Estimated completion	1 October 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Paravertebral blockade
• Thoracic epidural block — full drug profile →

Conditions studied

• Anesthesia — all drugs for Anesthesia →
• Thoracic Diseases — all drugs for Thoracic Diseases →

Sponsor

University of Birmingham

Who can join

18 and older, any sex, with Anesthesia or Thoracic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An estimated 7200 thoracotomies (surgical incision into the chest wall) are performed annually in the UK, most commonly to treat lung cancer. It is considered one of the most painful surgical procedures due to tissue, muscle and nerve damage from the incision, and as the wound heals. The normal breathing motion and nerve injury caused during surgery can result in a high risk of persistent pain for months after surgery. Chronic post-thoracotomy pain (CPTP) is defined as pain that recurs or persists at least two months following the surgery and can occur in up to half of these patients.

There are two commonly used for pain control during thoracotomy: Thoracic Epidural Block (TEB) blocks nerves on both sides of the chest at the spinal cord. It reduces painful nerve signals but may not abolish them completely. Para Vertebral Blockade is done only on the side of surgery and may completely block painful nerve signals from reaching the spinal cord. This total blockade of nerve signals could decrease the likelihood of developing chronic pain and could be uniquely effective in preventing long-term pain.

Over a period of 30 months this trial will be attempting to approach all patients undergoing a thoracotomy at approximately 20 UK hospitals to see if they wish to participate, and to look at the reasons they may not want to participate. We will follow up each participant for a maximum of a year following their surgery.

There is a qualitative intervention embedded within this study to support recruitment.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2).
   Shelley B, Goebel A, Grant S, Jackson L, et al · · 2023 · cited 8× · PMID 37996898 · DOI 10.1186/s13063-023-07463-1
2. Thoracic epidural versus paravertebral blockade for reducing chronic post-thoracotomy pain (TOPIC-2): an open-label, allocation-concealed, multicentre, randomised controlled trial
   Shelley B, Middleton L, Boyles R, Gilbert M, et al · · 2025 · DOI 10.1101/2025.08.07.25333201
3. Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy Pain: 2 (TOPIC 2)
   Shelley B, Goebel A, Grant S, Jackson L, et al · · 2023 · DOI 10.21203/rs.3.rs-2946661/v1