Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of celecoxib 400 mg and pregabalin 150 mg | Drug | Single dose of celecoxib 400 mg and pregabalin 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Three days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kemas MA Novriandi, MD | Contact | +628194830011 | Azkanovriandi1991@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andri MT Lubis | Department of Orthopaedic and Traumatology, Faculty of Medicine, Universitas Indonesia | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18033565 | Background | 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. | |
| 23375960 | Background | Boisgard 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
There are 3 separate groups defined by randomization:
Not provided
Not provided
Randomization performed by simple random sampling, the result is latern given to investigator in an envelope containing codes made by third party outside the research. Investigator and the patient do not know the allocation code
| Repeated dose of celecoxib 200 mg and pregabalin 75 mg | Drug | Repeated dose of celecoxib 200 mg and pregabalin 75 mg started 3 days before surgery |
|
| Placebo | Drug | Placebo |
|
| 22461810 | Background | Ferrata 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. |
| 20951814 | Background | Arden 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. |
| 10884204 | Background | Hayes 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. |
| 12429753 | Background | Holtzman 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. |
| 28533697 | Background | Pinto 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. |
| 28088207 | Background | Singh 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. |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |