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Ketorolac and Gabapentin's Impact on Pain Relief in Total Knee Arthroplasty

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Study Aim

This study is evaluating if a specific pre-operative medicine combination can help reduce pain after knee replacement surgery.

What is being tested

Ketorolac Tromethamine 30 MG/ML Prefilled Syringe

+ Gabapentin

+ Empty Medication Capsules

Drug
Who is being recruted

Arthritis+10

+ Joint Diseases

+ Musculoskeletal Diseases

From 40 to 80 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorAssiut University
Study ContactNour Shaaban Abdel-Aleem, ResidentMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2025

Actual date on which the first participant was enrolled.

This study is exploring how effective a pre-surgery dose of two medications, Ketorolac and Gabapentin, can be in reducing pain for patients undergoing a specific type of knee surgery called unilateral total knee arthroplasty (TKA). This surgery is often used to relieve pain from arthritis when other treatments haven’t worked. After this surgery, patients usually experience a lot of pain. By giving these medications before the surgery, researchers hope to prevent the body from becoming overly sensitive to pain, which can lead to less pain immediately after the surgery and potentially reduce the risk of developing long-term pain. This approach, called pre-emptive analgesia, aims to improve recovery by managing pain effectively from the start. In this study, participants will receive a combination of Ketorolac and Gabapentin before their knee surgery. Ketorolac is a type of non-steroidal anti-inflammatory drug (NSAID) that helps reduce pain and swelling, while Gabapentin is used to control nerve pain. Participants won't know if they are receiving the study medications or not, as this trial is double-blinded. Researchers will measure how well this combination works by looking at the levels of pain experienced by patients after the surgery and how quickly they recover. This study could lead to better pain management strategies for knee surgery patients, helping them recover faster and spend less time in the hospital.

Official TitleAnalgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial
NCT07047040
Principal SponsorAssiut University
Study ContactNour Shaaban Abdel-Aleem, ResidentMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsOsteoarthritisPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritis, Knee

Criteria

1 inclusion criteria required to participate
Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old

1 exclusion criteria prevent from participating
Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
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 II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Assiut University, Faculty of Medicine

Asyut, EgyptOpen Assiut University, Faculty of Medicine in Google Maps
Recruiting soonOne Study Center
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