Thoracic epidural blockade verses paravertebral blockade in reducing chronic post thoracotomy pain

A randomised controlled trial to investigate the effectiveness of ThOracic epidural and Paravertebral blockade In reducing Chronic post-thoracotomy pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45041624

Enrollment

Registered

2015-07-15

Start date

2015-07-01

Completion date

Unknown

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia, perioperative medicine and pain management Surgery

Interventions

All adults undergoing planned elective thoracotomy at study sites fulfilling inclusion and exclusion criteria will be approached and the trial written information sheets will be given to them and the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Elective open thoracotomy 3. Able to understand the study information and provide written informed consent 4. American Society of Anaesthesiologists physical status I, II or III 5. Not known to be pregnant

Exclusion criteria

Exclusion criteria: 1. Contraindication to TEB or PVB e.g. known allergy to local anaesthetics 2. Infection near the proposed puncture site 3. Coagulation disorders 4. Thoracic spine disorders 5. Chest wall resection 6. Emergency thoracic surgery 7. Previous thoracotomy 8. Likely inability to comply with completion of the study questionnaires

Design outcomes

Primary

Measure	Time frame
To establish the number of patients randomised as a proportion of those eligible to enter the study.	—

Secondary

Measure	Time frame
1. Assessment of effectiveness of patient identification and screening processes 2. Identification and analysis of any reasons for failure to recruit patients 3. Examination of the educational materials provided to surgeons and anaesthetists to ensure they are fit for purpose 4. Assessment of willingness of surgeons and anaesthetists to participate 5. Assessment of the effectiveness of the randomisation process of patients 6. Assessment of sustainability of single-blinding of patients to treatment allocation 7. Evaluation of robustness of data collection processes during patient?s hospital stay 8. The proportion of patients followed up at six months 9. Acceptability to and impact on patients of the interventions 10. Assessment of trial processes, including the choice of outcome measures and impact on staff 11. Derivation of the preliminary data from clinical outcome measures to inform the sample size calculation for the substantive study	—

Measure

Time frame

1. Assessment of effectiveness of patient identification and screening processes 2. Identification and analysis of any reasons for failure to recruit patients 3. Examination of the educational materials provided to surgeons and anaesthetists to ensure they are fit for purpose 4. Assessment of willingness of surgeons and anaesthetists to participate 5. Assessment of the effectiveness of the randomisation process of patients 6. Assessment of sustainability of single-blinding of patients to treatment allocation 7. Evaluation of robustness of data collection processes during patient?s hospital stay 8. The proportion of patients followed up at six months 9. Acceptability to and impact on patients of the interventions 10. Assessment of trial processes, including the choice of outcome measures and impact on staff 11. Derivation of the preliminary data from clinical outcome measures to inform the sample size calculation for the substantive study

—

Countries

England, United Kingdom

Contacts

Public ContactAmy Kerr

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026