Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Gabapentin, Empty Medication Capsules.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Osteoarthritis, Knee. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial
Overview
Evaluation of the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA
Detailed description
Elective total knee arthroplasty (TKA) is the gold standard for management of arthritis-associated pain and disability in osteoarthritis patients who have failed non-operative treatment modalitiesFollowing TKA, patients experience severe pain mediated by multiple pathways Painful stimuli to the body are detected by the free endings of peripheral nerves called nociceptors. Pre-emptive analgesia is analgesia given before the onset of painful stimuli to prevent central sensitization of nervous system to subsequent stimuli that could increase pain Studies have shown that pre-emptive analgesia reduce immediate postoperative pain and also prevent the development of chronic pain by decreasing altered sensory processing . Multimodal analgesia is the rational approach to pain management since no single analgesia targets all types of pain Multimodal analgesia, which is the use of at least 2 agents with differing mechanisms for pain control, has been shown to reduce hospital length of stay by 1.2 days and rehabilitation length of stay by 10 to 13 days compared with traditional postoperative analgesia. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). It is a cost-effective non selective cox inhibitor it inhibits prostaglandin biosynthesis. It is a potent analgesic with moderate anti-inflammatory.it inhibits platelet aggregation and increases bleeding time GABA analogues like Gabapentin is a structural analogue of gamma amino butyric acid, which was introduced in 1994 as an antiepileptic drug, particularly for partial seizures These drugs supress the hyper excitability of dorsal horn neurons caused due to tissue damage. They are also known to bind to the alpha 2 - delta subunit of voltage gated calcium channels and they have anxiolytic effect In this study we will assess the analgesic efficacy of pre-operative dose of combined ketorolac and Gabapentin in patients undergoing TKA.
Interventions
- Drug Ketorolac Tromethamine 30 MG/ML Prefilled Syringe
a pre-operative dose of ketorolac and gabapentin is given to the patients undergoing unilateral TKA one hour prior to surgery, then a post-operative pain scores will be recorded - Drug Gabapentin
a pre-operative dose of ketorolac and gabapentin is given to the patients undergoing unilateral TKA one hour prior to surgery, then a post-operative pain scores will be recorded - Drug Empty Medication Capsules
two empty capsules of gabapentin
Primary outcome measures
- evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA. [Time frame: during the first 24 hours post-operatively]
Secondary outcome measures (3)
- assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption [Time frame: during the first 24 hours post-operatively]
- investigate the safety profile of pre-operative ketorolac and gabapentin [Time frame: during the first 24 hours post-operatively]
- evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery [Time frame: during the month after surgery]
Eligibility criteria
Inclusion criteria
- Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old
Exclusion criteria
- Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Assiut University, Faculty of Medicine — Asyut
Publications
- Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9. PMID 15195936
- Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006. PMID 10422923
- Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7. PMID 19258965
- Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26. PMID 23703420
Identifiers
NCT: NCT07047040 · pre-operative analgesia