Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Osteoarthritis, Knee

• Registration Number: NCT07047040
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Study Start: 2025-07-15
• Primary Completion: 2027-10-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assiut University, Faculty of Medicine; 🇪🇬 Asyut, أسيوط, Egypt