Peri-operative anti-inflammatory analgesia Surgery Peri-operative analgesia
Conditions
Interventions
Dyloject® (75 mg) single intravenous bolus or Voltarol® ampoules (75 mg) single intravenous infusion will be given pre-operatively prior to spinal anaesthesia for surgery and cerebrospinal fluid sampl
Sponsors
Barts and The London NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged at least 18 years 2. Scheduled to undergo surgery performed under spinal anaesthesia 3. Patients must be inpatients 4. Patient has given written informed consent
Exclusion criteria
Exclusion criteria: 1. History of bleeding diathesis or use of anticoagulant or antiplatelet agent 2. History of spinal or neurological disease (including raised intracranial pressure), or surgery contraindicating spinal anaesthesia 3. Use of aspirin within 72 hours prior to surgery 4. Use of other non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol or steroids within 12 hours before surgery 5. Hypersensitivity to diclofenac or local anaesthetics 6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or blood urea nitrogen (BUN) greater than 1.5 x the upper limit of the reference range, or creatinine greater than the upper limit of the reference range 7. Any other abnormal laboratory results considered clinically significant in relation to this study by the investigator 8. Presence of oliguria, anaemia, hypotension or hypovolaemia 9. Contraindications to NSAID/diclofenac 10. Patients who are unwilling or unable to conform to the protocol 11. Patients who have received an unlicensed drug less than 30 days prior to the study 12. Patients who have been previously admitted to the study 13. Pregnant or lactating females or females of child-bearing potential who are unwilling to undertake a pregnancy test (urinary beta-human chorionic gonadotropin [B-HCG]) 14. A bloody tap (visible blood in CSF) 15. Patients with a hypersensitivity to the excipients hydroxypropylbetadex (HPßCD) or monothioglycerol 16. Operations with high risk of haemorrhage 17. Patients who are considered unsuitable by the responsible anaesthetist - for whom spinal anaesthesia is deemed to constitute an unacceptable, increased risk 18. Patients who are involved in existing research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterisation of the CSF diclofenac kinetics following administration of intravenous Dyloject®. The patients will receive the drug at 65, 35 and 5 minutes prior to CSF sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Characterise CSF PGE2 levels in the normal uninjured human with or without diclofenac 2. Establish baseline CSF and plasma prostaglandins and cytokine levels 3. Examine the relationship between CNS and plasma PGE2 levels 4. Establish proof of concept for further analyses: an optional continuation of this pilot study is proposed dependant on interim analysis of the first phase. This would entail a further 18 patients entering the study. | — |
Countries
United Kingdom
Outcome results
None listed