Pain, PostoperativePhase 2/3NCT07047040
Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin
A Phase 2/3 study testing Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Gabapentin and Empty Medication Capsules in people with Pain, Postoperative and Osteoarthritis, Knee, run by Assiut University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain, Postoperative, Osteoarthritis, Knee
- What is being tested?
- Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Gabapentin and Empty Medication Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 30 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old
Who cannot join
- Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University, Faculty of Medicine
Asyut, Asyut Governorate, 71515
About this study
Official title: Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial
Evaluation of the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA
Read the 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
- Being tested
- Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Gabapentin, Empty Medication Capsules
- Keywords
- total knee replacement, pre-operative analgesia, ketorolac, gabapentin
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac Tromethamine 30 MG/ML Prefilled SyringeDrug
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
GabapentinDrug
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 CapsulesDrug
two empty capsules of gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | 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 Receives: Drug: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe; Drug: Gabapentin |
| control group | Placebo comparator | control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia Receives: Drug: Empty Medication Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA.
asses pain postoperatively at 6,12,24 hours using VAS score
Measured: during the first 24 hours post-operatively
Secondary outcomes (3)
assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption
by recording the total amount of opioids in both groups and comparing them
Measured: during the first 24 hours post-operatively
investigate the safety profile of pre-operative ketorolac and gabapentin
by recording any side effects of these drugs during the study
Measured: during the first 24 hours post-operatively
evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery
by using Time UP and Go(TUG) Test in both groups and comparing them
Measured: during the month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients scheduled for unilateral total knee replacement ranging from 40-80 years of age will be selected. Patients will be randomized into two groups. Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule. While control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia. Pain will be assessed postoperatively by visual analogue score at,6 hours, 12 hours and 24 hours. total dose of analgesia in first 24 hours will be recorded. Any complications will be recorded in first 24 hours post- operative period. Follow up: Visual Analog Scale (VAS) will be used at 6, 12, 24 hours post-surgery for assessment of Pain. Any side effects or complications will be recorded. Time Up and Go (TUG) test after 24hrs post-operative. Oxford knee score (OKS) after 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Shaaban Abdel-Aleem Mohamed, Assiut University
- Investigators
- Hatem Mohamed Bakr, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047040
- Sponsor's protocol ID
- pre-operative analgesia
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.
PubMed 15195936Capdevila 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.
PubMed 10422923Hebl 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.
PubMed 19258965Lee 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.
PubMed 23703420
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Pre-operative Dose of Ketorolac And Gabapentin in Patients Undergoing Unilateral Total Knee Arthroplasty A Randomized Double Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT07047040
- Acronym / sponsor ID
- pre-operative analgesia
- Conditions
- Pain, Postoperative, Osteoarthritis, Knee
- Keywords
- total knee replacement, pre-operative analgesia, ketorolac, gabapentin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients scheduled for unilateral total knee replacement ranging from 40-80 years of age will be selected. Patients will be randomized into two groups. Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule. While control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia. Pain will be assessed postoperatively by visual analogue score at,6 hours, 12 hours and 24 hours. total dose of analgesia in first 24 hours will be recorded. Any complications will be recorded in first 24 hours post- operative period. Follow up: Visual Analog Scale (VAS) will be used at 6, 12, 24 hours post-surgery for assessment of Pain. Any side effects or complications will be recorded. Time Up and Go (TUG) test after 24hrs post-operative. Oxford knee score (OKS) after 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Drug: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Drug: GabapentinExperimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule, one hour prior to administration of spinal anesthesia |
| control group | Placebo comparator | Drug: Empty Medication Capsulescontrol group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old
Key exclusion criteria (1 listed)
- Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac Tromethamine 30 MG/ML Prefilled Syringea 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 | Drug | Experimental group |
| Gabapentina 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 | Drug | Experimental group |
| Empty Medication Capsulestwo empty capsules of gabapentin | Drug | control group |
Primary outcome
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
3 secondary outcomes
assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption
Time frame: during the first 24 hours post-operatively
investigate the safety profile of pre-operative ketorolac and gabapentin
Time frame: during the first 24 hours post-operatively
evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery
Time frame: during the month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 15195936Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.
- Background: PubMed 10422923Capdevila 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.
- Background: PubMed 19258965Hebl 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.
- Background: PubMed 23703420Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem Mohamed Bakr, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketorolac Tromethamine 30 MG/ML Prefilled Syringe, Gabapentin and Empty Medication Capsules in people with Pain, Postoperative and Osteoarthritis, Knee, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nour Shaaban Abdel-Aleem, Resident (+00201157257047, Nour.162663325@med.aun.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07047040, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.