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NCT Number: NCT07047040

Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut University, Faculty of Medicine

Asyut, Asyut Governorate, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine 30 MG/ML Prefilled Syringe

Drug

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

Gabapentin

Drug

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

Empty Medication Capsules

Drug

two empty capsules of gabapentin

Primary outcomes

  1. 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

    asses pain postoperatively at 6,12,24 hours using VAS score

Secondary outcomes

  1. assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption

    Time frame: during the first 24 hours post-operatively

    by recording the total amount of opioids in both groups and comparing them

  2. investigate the safety profile of pre-operative ketorolac and gabapentin

    Time frame: during the first 24 hours post-operatively

    by recording any side effects of these drugs during the study

  3. evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery

    Time frame: during the month after surgery

    by using Time UP and Go(TUG) Test in both groups and comparing them

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Ahmed Mahran, Professor

CONTACT

[email protected]

+00201006134669

Nour Shaaban Abdel-Aleem, Resident

CONTACT

[email protected]

+00201157257047

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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