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

NCT03677856 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1026

Last updated 2019-09-26

No results posted yet for this study

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

Interventions

PROCEDURE

Paravertebral blockade

Type of anaesthesia

PROCEDURE

Thoracic epidural block

Type of anaesthesia

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Fang Gao Smith, MD · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2022-01-08
Completion
2022-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03677856 on ClinicalTrials.gov