Anesthesia Clinical Trial
— TOPIC-2Official title:
A Randomised Controlled Trial to Investigate the Effectiveness of ThOracic Epidural and Paravertebral Blockade In Reducing Chronic Post- Thoracotomy Pain: 2
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.
Status | Recruiting |
Enrollment | 1026 |
Est. completion date | October 1, 2022 |
Est. primary completion date | January 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged =18 years - Elective open thoracotomy - Able to provide written informed consent - Willingness to complete study questionnaires up until 12 months post randomisation Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Heartlands Hospital | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Complications of regional anaesthesia | Complications of regional anaesthesia are protocol-defined | 3, 6 and 12 months post randomisation | |
Secondary | Incidence of surgical complications | as classified by the European Society of Thoracic Surgeons | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Incidence of surgical complications | as classified by the European Society of Thoracic Surgeons | 3, 6 and 12 months post randomisation | |
Secondary | Incidence of Major Post-operative pulmonary complications | as classified by StEP Core Outcome Measures in Perioperative and Anaesthetic Care | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Incidence of Major Post-operative pulmonary complications | as classified by StEP Core Outcome Measures in Perioperative and Anaesthetic Care | 3, 6 and 12 months post randomisation | |
Secondary | Incidence of critical care admission | Any admission to critical care extracted from hospital records | 3, 6 and 12 months post randomisation | |
Secondary | Mortality | All deaths due to all causes | 3, 6 and 12 months post randomisation | |
Secondary | Analgesic use | all forms of analgesic use for trial-related pain as reported by patient | 3, 6 and 12 months post randomisation | |
Secondary | Acute pain | Patient reported worst chest pain on visual analogue scale (0-10) with 10 being the worst | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Acute pain | Patient reported via Brief Pain Inventory Interference score (0-10, higher = worse) | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Acute pain | Patient reported worst chest pain via Short Form McGill Pain Score (0-10 higher = worse score) | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Acute pain | Patient reported worst chest pain on visual analogue scale (0-10) with 10 being the worst | 3, 6 and 12 months post randomisation | |
Secondary | Acute pain | Patient reported worst chest pain via Brief Pain Inventory Interference Score (0-10 higher = worse score) | 3, 6 and 12 months post randomisation | |
Secondary | Acute pain | Patient reported worst chest via Short Form McGill Pain Score (0-10 higher = worse score) | 3, 6 and 12 months post randomisation | |
Secondary | Health resource use | Targeted collection of health resource use data from hospital records | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Health resource use | Targeted collection of health resource use data from hospital records | 3, 6 and 12 months post randomisation | |
Secondary | General health-related quality of life Index Score | Patient reported using EQ-5D-5L questionnaire Index Score (1.0 = best outcome) | 3, 6 and 12 months post randomisation | |
Secondary | General health-related quality of life Thermometer Score | Patient reported using EQ-5D-5L questionnaire Thermometer Score (0-100, 100 = best outcome) | 3, 6 and 12 months post randomisation | |
Secondary | General health-related quality of life | Patient reported using Hospital Anxiety and Depression Score (0-21, lower = better) | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | General health-related quality of life | Patient reported using Hospital Anxiety and Depression Score (0-21, lower = better) | 3, 6 and 12 months post randomisation | |
Secondary | Patient Satisfaction with care provided | Patient reported on Likert scale (Very dissatisfied/ Dissatisfied/ Satisfied/ Very satisfied) | Until discharge from hospital post randomisation eg a maximum of 30 days | |
Secondary | Patient Satisfaction with care provided | Patient reported on Likert scale (Very dissatisfied/ Dissatisfied/ Satisfied/ Very satisfied) | 3, 6 and 12 months post randomisation | |
Secondary | Incidence of Serious Adverse Events | Protocol-defined events meeting the accepted trial definition of "serious" | 3, and 6 months post randomisation |
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