Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin

NCT ID: NCT07047040

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2027-12-30

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.

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

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

Group Type: ACTIVE_COMPARATOR

Ketorolac Tromethamine 30 MG/ML Prefilled Syringe

Intervention Type: 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

Intervention Type: 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

control group

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

Group Type: PLACEBO_COMPARATOR

Empty Medication Capsules

Intervention Type: DRUG

two empty capsules of gabapentin

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Empty Medication Capsules

two empty capsules of gabapentin

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nour Shaaban Abdel-Aleem Mohamed

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatem Mohamed Bakr, Professor

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University, Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Nour Shaaban Abdel-Aleem, Resident

Role: CONTACT

Nour.162663325@med.aun.eg

+00201157257047

Mohamed Ahmed Mahran, Professor

Role: CONTACT

drmahran@aun.edu.eg

+00201006134669

References

Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.

Reference Type: BACKGROUND

PMID: 15195936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10422923 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19258965 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23703420 (View on PubMed)

Other Identifiers

pre-operative analgesia

Identifier Type: -

Identifier Source: org_study_id