Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin

Assiut University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Pain, Postoperative; Osteoarthritis, Knee

Treatments: Drug: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe; Drug: Empty Medication Capsules; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT07047040

pre-operative analgesia

Details and patient eligibility

About

Evaluation of the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule, one hour prior to administration of spinal anesthesia

Treatment:

Drug: Gabapentin

Drug: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe

control group

Placebo Comparator group

Description:

control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia

Treatment:

Drug: Empty Medication Capsules