Osteoarthritis, Knee, Pain, Postoperative
Conditions
Keywords
total knee replacement, pre-operative analgesia, ketorolac, gabapentin
Brief summary
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
DRUGKetorolac 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
DRUGGabapentin
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
two empty capsules of gabapentin
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Patients scheduled for unilateral total knee replacement ranging from 40-80 years of age will be selected. Patients will be randomized into two groups. Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule. While control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia. Pain will be assessed postoperatively by visual analogue score at,6 hours, 12 hours and 24 hours. total dose of analgesia in first 24 hours will be recorded. Any complications will be recorded in first 24 hours post- operative period. Follow up: Visual Analog Scale (VAS) will be used at 6, 12, 24 hours post-surgery for assessment of Pain. Any side effects or complications will be recorded. Time Up and Go (TUG) test after 24hrs post-operative. Oxford knee score (OKS) after 4 weeks.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA. | during the first 24 hours post-operatively | asses pain postoperatively at 6,12,24 hours using VAS score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption | during the first 24 hours post-operatively | by recording the total amount of opioids in both groups and comparing them |
| investigate the safety profile of pre-operative ketorolac and gabapentin | during the first 24 hours post-operatively | by recording any side effects of these drugs during the study |
| evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery | during the month after surgery | by using Time UP and Go(TUG) Test in both groups and comparing them |
Countries
Egypt
Contacts
Primary ContactNour Shaaban Abdel-Aleem, Resident
Backup ContactMohamed Ahmed Mahran, Professor
Outcome results
None listed