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

Not Applicable

Completed

• Conditions: Anaesthesia, perioperative medicine and pain management; Surgery

• Registration Number: ISRCTN45041624
• Lead Sponsor: Heart of England NHS Foundation Trust

Brief Summary

2019 Results article in http://dx.doi.org/10.1136/bmjopen-2018-023679 results (added 22/07/2020) 2016 Protocol article in https://pubmed.ncbi.nlm.nih.gov/27909035/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-15
• Study Completion: 2016-12-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the number of patients randomised as a proportion of those eligible to enter the study.

Secondary Outcome Measures

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