A Phase 4 interventional study of Pregabalin and Ketamine infusion in Pain, Hyperalgesia and Chronic Illness, sponsored by Barts & The London NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Barts & The London NHS Trust · Phase 4, Interventional, and Prevention
The use of pre-emptive analgesia to prevent pain following sternotomy for cardiac surgery
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's enrollment of 150 is above the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Neuralgia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo capsules and Placebo infusion
Drug: Placebo capsules · Drug: Placebo infusion
Pregabalin capsules and Placebo infusion
Drug: Pregabalin · Drug: Placebo infusion
Pregabalin capsules + Ketamine infusion
Drug: Pregabalin · Drug: Ketamine infusion
150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
0.1mg/kg/hr for 48 hours post operatively
Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days
Normal saline placebo intravenous infusion for 48 hours
Numerical Rating Scale (NRS) pain score (around sternotomy incision site) post surgery, at rest and following 3 maximal coughs.
Time frame: 3 and 6 months post sternotomy
Total morphine consumption at 24 hours post surgery
Time frame: 24 hours post surgery
Visual Analogue Scale (VAS) scores at 24 hrs post surgery, at rest and following 3 maximal coughs
Time frame: 24 hours post surgery
Sedation (including pCO2) and nausea scores at 24 hours post surgery
Time frame: 24 hours post surgery
Side effect episodes (dizziness, confusion, blurred vision)
Time frame: First 48 hours
Time to extubation
Time frame: Post op recovery period
Length of stay in intensive care and hospital
Time frame: Post operative - acute
28 day mortality
Time frame: 28 days post surgery
Neuropathic pain score
S-LANSS (Short form Leeds Assessment of Neuropathic Symptoms and Signs)
Time frame: 3 and 6 months post surgery
Quality of Life
EQ-5D validated scoring scale
Time frame: 3 and 6 months
Survival
Time frame: 3 and 6 months
QST measurements
Pain Pressure Thresholds (PPT) using algometry, both pre and post Diffuse Noxious Inhibitory Control (DNIC) Tactile and Pain Detection Thresholds with mechanical static stimulus using Von Frey hairs (VFH) Dynamic assessment of temporal summation and secondary hyeralgesia with VFH
Time frame: Pre op and post op at 72hrs and 3 months
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Pregabalin · Ketamine
Barts & The London NHS Trust →