Arthroplasty ComplicationsPhase 2/3NCT05509946
Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA
A Phase 2/3 study testing Single dose of celecoxib 400 mg and pregabalin 150 mg and Repeated dose of celecoxib 200 mg and pregabalin 75 mg in people with Arthroplasty Complications and Analgetic, run by Universitas Indonesia.
Trial summary
This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Complications, Analgetic, Celecoxib
- What is being tested?
- Single dose of celecoxib 400 mg and pregabalin 150 mg and Repeated dose of celecoxib 200 mg and pregabalin 75 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Apr 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- Patients who come to the RSCM Orthopedic Polyclinic
- Patients undergoing THA operasi surgery
- Patients with Primary and Secondary Pelvic Osteoarthritis
- The patient is taking anti-pain and anti-inflammatory drugs regularly
Who cannot join
- Patients with mental disorders
- Patients with a history of renal impairment
- Pelvic arthritis patients due to rheumatoid arthritis or infection
- Patients with diabetes and obesity
- Allergy to non-steroidal inflammatory drugs
- Asthma history
- Coagulation disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preemptive Analgesia Combination of Celecoxib and Pregabalin in Total Hip Arthroplasty: Comparison of the Effects of Single Dose and Repeated Doses (Double-Blind Randomized Clinical Trial)
This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. The subject of this study is adult patient who will be performed total hip arthroplasty.
Read the detailed description
- Research design This is a double-blind, randomized clinical trial which aimed to evaluate the effect of preemptive analgesia combined with Celecoxib and Pregabalin on acute post-THA pain.
- Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
- Study time This study will be conducted in October 2022 - April 2023
- Population and sample The target population of this study is adult patients undergoing THA surgery. The randomization technique used in this study is a simple randomization technique. Researchers randomly determine the allocation of samples without looking at subjects' status in the population.
- Inclusion criteria
- Patients >18 years old
- Patients who come to the RSCM Orthopedic Polyclinic
- Patients undergoing THA surgery
- Patients with Primary and Secondary Pelvic Osteoarthritis
- The patient is taking anti-pain and anti-inflammatory drugs regularly
- Exclusion criteria
- Patients with mental disorders
- Patients with a history of renal impairment
- Pelvic arthritis patients due to rheumatoid arthritis or infection
- Patients with diabetes and obesity
- Allergy to non-steroidal inflammatory drugs
- Asthma history
- Coagulation disorders
- Patients in the study procedure experienced an incident of severe pain that required another analgesic regimen
- History of hypersensitivity to NSAIDs or sulfonamides
- Conditions
- Arthroplasty Complications, Analgetic, Celecoxib, Pregabalin
- Being tested
- Single dose of celecoxib 400 mg and pregabalin 150 mg, Repeated dose of celecoxib 200 mg and pregabalin 75 mg, Placebo
- Keywords
- total hip arthroplasty, celecoxib, pregabalin, preemptive analgetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of celecoxib 400 mg and pregabalin 150 mgDrug
Single dose of celecoxib 400 mg and pregabalin 150 mg
Repeated dose of celecoxib 200 mg and pregabalin 75 mgDrug
Repeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single dose of celecoxib 400 mg and pregabalin 150 mg | Experimental | Single dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery Receives: Drug: Single dose of celecoxib 400 mg and pregabalin 150 mg |
| Repeated dose of celecoxib 200 mg and pregabalin 75 mg | Active comparator | Repeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery Receives: Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Acute pain measured in the morning before activity after surgery. Measured by numeric pain rating scale 0 - 10 which lower score means less pain while higher score means more pain
Measured: After surgery for three days
Total consumption of morphine
Morphine is an opioid analgesic, in this study it was used as an analgesic as well as an objective parameter to assess the effectiveness of celecoxib and pregabalin. Given with a patient control analgesia (PCA) device. Dosage of morphine used
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- There are 3 separate groups defined by randomization: 1. single dose of combined celecoxib 400 mg and pregabalin 150 mg an hour before surgery 2. repeated dose of combined celexocib 200 mg twice a day and pregabalin 75 mg twice a day, administered 3 days before surgery 3. placebo administered an hour before surgery
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemas Muhammad Azka Novriandi, Universitas Indonesia
- Investigators
- Andri MT Lubis, Study director, Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509946
- Sponsor's protocol ID
- ID2564
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sathappan SS, Strauss EJ, Ginat D, Upasani V, Di Cesare PE. Surgical challenges in complex primary total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):534-41.
PubMed 18033565Boisgard S, Descamps S, Bouillet B. Complex primary total hip arthroplasty. Orthop Traumatol Surg Res. 2013 Feb;99(1 Suppl):S34-42. doi: 10.1016/j.otsr.2012.11.008. Epub 2013 Feb 1.
PubMed 23375960Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
PubMed 22461810Arden NK, Kiran A, Judge A, Biant LC, Javaid MK, Murray DW, Carr AJ, Cooper C, Field RE. What is a good patient reported outcome after total hip replacement? Osteoarthritis Cartilage. 2011 Feb;19(2):155-62. doi: 10.1016/j.joca.2010.10.004. Epub 2010 Oct 15.
PubMed 20951814Hayes JH, Cleary R, Gillespie WJ, Pinder IM, Sher JL. Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty? J Arthroplasty. 2000 Jun;15(4):448-52. doi: 10.1054/arth.2000.4346.
PubMed 10884204Holtzman J, Saleh K, Kane R. Effect of baseline functional status and pain on outcomes of total hip arthroplasty. J Bone Joint Surg Am. 2002 Nov;84(11):1942-8. doi: 10.2106/00004623-200211000-00006.
PubMed 12429753Pinto PR, McIntyre T, Araujo-Soares V, Costa P, Ferrero R, Almeida A. A comparison of predictors and intensity of acute postsurgical pain in patients undergoing total hip and knee arthroplasty. J Pain Res. 2017 May 9;10:1087-1098. doi: 10.2147/JPR.S126467. eCollection 2017.
PubMed 28533697Singh JA, Noorbaloochi S, Knutson KL. Cytokine and neuropeptide levels are associated with pain relief in patients with chronically painful total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2017 Jan 14;18(1):17. doi: 10.1186/s12891-016-1375-2.
PubMed 28088207
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia Combination of Celecoxib and Pregabalin in Total Hip Arthroplasty: Comparison of the Effects of Single Dose and Repeated Doses (Double-Blind Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05509946
- Acronym / sponsor ID
- ID2564
- Conditions
- Arthroplasty Complications, Analgetic, Celecoxib, Pregabalin
- Keywords
- total hip arthroplasty, celecoxib, pregabalin, preemptive analgetic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 22 Aug 2022 (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.
This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. The subject of this study is adult patient who will be performed total hip arthroplasty.
Detailed description
- Research design This is a double-blind, randomized clinical trial which aimed to evaluate the effect of preemptive analgesia combined with Celecoxib and Pregabalin on acute post-THA pain.
- Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
- Study time This study will be conducted in October 2022 - April 2023
- Population and sample The target population of this study is adult patients undergoing THA surgery. The randomization technique used in this study is a simple randomization technique. Researchers randomly determine the allocation of samples without looking at subjects' status in the population.
- Inclusion criteria
- Patients >18 years old
- Patients who come to the RSCM Orthopedic Polyclinic
- Patients undergoing THA surgery
- Patients with Primary and Secondary Pelvic Osteoarthritis
- The patient is taking anti-pain and anti-inflammatory drugs regularly
- Exclusion criteria
- Patients with mental disorders
- Patients with a history of renal impairment
- Pelvic arthritis patients due to rheumatoid arthritis or infection
- Patients with diabetes and obesity
- Allergy to non-steroidal inflammatory drugs
- Asthma history
- Coagulation disorders
- Patients in the study procedure experienced an incident of severe pain that required another analgesic regimen
- History of hypersensitivity to NSAIDs or sulfonamides
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- There are 3 separate groups defined by randomization: 1. single dose of combined celecoxib 400 mg and pregabalin 150 mg an hour before surgery 2. repeated dose of combined celexocib 200 mg twice a day and pregabalin 75 mg twice a day, administered 3 days before surgery 3. placebo administered an hour before surgery
| Arm | Type | Receives |
|---|---|---|
| Single dose of celecoxib 400 mg and pregabalin 150 mg | Experimental | Drug: Single dose of celecoxib 400 mg and pregabalin 150 mgSingle dose of celecoxib 400 mg and pregabalin 150 mg administered an hour before surgery |
| Repeated dose of celecoxib 200 mg and pregabalin 75 mg | Active comparator | Drug: Repeated dose of celecoxib 200 mg and pregabalin 75 mgRepeated dose of celecoxib 200 mg twice a day and pregabalin 75 mg twice a day administered starting from 3 days before surgery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients >18 years old
- Patients who come to the RSCM Orthopedic Polyclinic
- Patients undergoing THA operasi surgery
- Patients with Primary and Secondary Pelvic Osteoarthritis
- The patient is taking anti-pain and anti-inflammatory drugs regularly
Key exclusion criteria (7 listed)
- Patients with mental disorders
- Patients with a history of renal impairment
- Pelvic arthritis patients due to rheumatoid arthritis or infection
- Patients with diabetes and obesity
- Allergy to non-steroidal inflammatory drugs
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 |
|---|---|---|
| Single dose of celecoxib 400 mg and pregabalin 150 mgSingle dose of celecoxib 400 mg and pregabalin 150 mg | Drug | Single dose of celecoxib 400 mg and pregabalin 150 mg |
| Repeated dose of celecoxib 200 mg and pregabalin 75 mgRepeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery | Drug | Repeated dose of celecoxib 200 mg and pregabalin 75 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Postoperative Pain
Time frame: After surgery for three days
Acute pain measured in the morning before activity after surgery. Measured by numeric pain rating scale 0 - 10 which lower score means less pain while higher score means more pain
Total consumption of morphine
Time frame: Three days
Morphine is an opioid analgesic, in this study it was used as an analgesic as well as an objective parameter to assess the effectiveness of celecoxib and pregabalin. Given with a patient control analgesia (PCA) device. Dosage of morphine used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 18033565Sathappan SS, Strauss EJ, Ginat D, Upasani V, Di Cesare PE. Surgical challenges in complex primary total hip arthroplasty. Am J Orthop (Belle Mead NJ). 2007 Oct;36(10):534-41.
- Background: PubMed 23375960Boisgard S, Descamps S, Bouillet B. Complex primary total hip arthroplasty. Orthop Traumatol Surg Res. 2013 Feb;99(1 Suppl):S34-42. doi: 10.1016/j.otsr.2012.11.008. Epub 2013 Feb 1.
- Background: PubMed 22461810Ferrata P, Carta S, Fortina M, Scipio D, Riva A, Di Giacinto S. Painful hip arthroplasty: definition. Clin Cases Miner Bone Metab. 2011 May;8(2):19-22.
- Background: PubMed 20951814Arden NK, Kiran A, Judge A, Biant LC, Javaid MK, Murray DW, Carr AJ, Cooper C, Field RE. What is a good patient reported outcome after total hip replacement? Osteoarthritis Cartilage. 2011 Feb;19(2):155-62. doi: 10.1016/j.joca.2010.10.004. Epub 2010 Oct 15.
- Background: PubMed 10884204Hayes JH, Cleary R, Gillespie WJ, Pinder IM, Sher JL. Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty? J Arthroplasty. 2000 Jun;15(4):448-52. doi: 10.1054/arth.2000.4346.
- Background: PubMed 12429753Holtzman J, Saleh K, Kane R. Effect of baseline functional status and pain on outcomes of total hip arthroplasty. J Bone Joint Surg Am. 2002 Nov;84(11):1942-8. doi: 10.2106/00004623-200211000-00006.
- Background: PubMed 28533697Pinto PR, McIntyre T, Araujo-Soares V, Costa P, Ferrero R, Almeida A. A comparison of predictors and intensity of acute postsurgical pain in patients undergoing total hip and knee arthroplasty. J Pain Res. 2017 May 9;10:1087-1098. doi: 10.2147/JPR.S126467. eCollection 2017.
- Background: PubMed 28088207Singh JA, Noorbaloochi S, Knutson KL. Cytokine and neuropeptide levels are associated with pain relief in patients with chronically painful total knee arthroplasty: a pilot study. BMC Musculoskelet Disord. 2017 Jan 14;18(1):17. doi: 10.1186/s12891-016-1375-2.
- 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. This study is not recruiting at the moment.
Andri MT Lubis study director
Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Single dose of celecoxib 400 mg and pregabalin 150 mg and Repeated dose of celecoxib 200 mg and pregabalin 75 mg in people with Arthroplasty Complications and Analgetic, run by Universitas Indonesia.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kemas MA Novriandi, MD (+628194830011, Azkanovriandi1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: After surgery for three days). The study lists 2 primary outcomes in all. 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 NCT05509946, which also lists 8 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 24 Aug 2022.