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

NCT03677856 | Unknown DMC

• 1 other identifier: RG_18-0108
• Study Type: interventional
• Target: 1,026
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Thoracic Diseases

Keywords

Paravertebral block; Thoracic epidural block; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic pain: incidence = score > 40 on visual analogue score

  Patient reported pain lasting at least 3 months as measured by visual analogue score

  6 months post trial thoracotomy

Secondary Outcomes (23)

• Complications of regional anaesthesia

  3, 6 and 12 months post randomisation

• Incidence of surgical complications

  Until discharge from hospital post randomisation eg a maximum of 30 days

• Incidence of surgical complications

  3, 6 and 12 months post randomisation

• Incidence of Major Post-operative pulmonary complications

  Until discharge from hospital post randomisation eg a maximum of 30 days

• Incidence of Major Post-operative pulmonary complications

  3, 6 and 12 months post randomisation

Study Arms (2)

Paravertebral Blockade

EXPERIMENTAL

Anaesthesia to single side of the patient's chest

Procedure: Paravertebral blockade

Thoracic epidural block

ACTIVE COMPARATOR

Anaesthesia to both sides of the patient's chest

Procedure: Thoracic epidural block

Interventions

Paravertebral blockade PROCEDURE

Type of anaesthesia

Paravertebral Blockade

Thoracic epidural block PROCEDURE

Type of anaesthesia

Thoracic epidural block

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years
• Elective open thoracotomy
• Able to provide written informed consent
• Willingness to complete study questionnaires up until 12 months post randomisation

You may not qualify if:

• Contraindication to TEB or PVB e.g. known allergy to local anaesthetics; infection near the proposed puncture site; coagulation disorders, thoracic spine disorders
• Surgery for chest wall pathology on the side of surgery
• Previous thoracotomy
• Median sternotomy within 90 days

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Heartlands Hospital

Birmingham, West Midlands, United Kingdom

RECRUITING

Related Publications (1)

• Shelley B, Goebel A, Grant S, Jackson L, Jarrett H, Jepson M, Kerr A, Marczin N, Mehta R, Melody T, Middleton L, Naidu B, Szentgyorgyi L, Tearne S, Watkins B, Wilson M, Worrall A, Yeung J, Smith FG. 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). Trials. 2023 Nov 23;24(1):748. doi: 10.1186/s13063-023-07463-1.

  PMID: 37996898 DERIVED

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Fang Gao Smith, MD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugh Jarrett, MSc

CONTACT

00 44 121 415 9134; h.jarrett@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-centre, parallel group, superiority, with an internal pilot, in a 1:1 ratio

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 19, 2018
• Study Start: January 8, 2019
• Primary Completion: January 8, 2022
• Study Completion: October 1, 2022
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)