- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924412
Parecoxib in Total Knee Arthroplasty
December 13, 2023 updated by: Julian Aliste, University of Chile
A Randomized Comparison Between Parecoxib and Placebo Added to a Standard Perioperative Analgesic Protocol for Total Knee Arthroplasty
Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain.
Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols.
Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2).
Clinical trials have shown that it does not alter platelet function or gastric mucosa.
A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group.
This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen.
The morphine consumption was selected as the primary outcome.
The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julián Aliste
- Phone Number: +56229788209
- Email: julian.aliste@uchile.cl
Study Locations
-
-
Metropolitan
-
Santiago, Metropolitan, Chile, 8380420
- Recruiting
- Hospital Clínico Universidad de Chile
-
Contact:
- JULIAN ALISTE
- Phone Number: 229782221
- Email: julian.aliste@uchile.cl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
ASA I - III BMI 20 - 35 (kg/m2)
Exclusion Criteria:
- Adults who are not capable of giving their own consent
- Pre-existing neuropathy (assessed in the history and physical examination)
- Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl)
- Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt)
- Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib
- Pregnancy
- Chronic pain syndromes that require the use of opioids at home
- Known history of sulfa allergy
- History of ischemic heart disease
- History of chronic gastritis or peptic ulcer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parecoxib
This arm will receive intravenous parecoxib in the intraoperative period.
|
40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión
|
Placebo Comparator: Placebo
This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group
|
Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption
Time Frame: 24 hours
|
Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Basal quadriceps strength in the operative side
Time Frame: 1 hour before surgery
|
Leg extension strength measured with a handheld dynamometer
|
1 hour before surgery
|
Basal level of pain during leg extension in the operative side
Time Frame: 1 hour before surgery
|
Pain level measured with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
1 hour before surgery
|
Basal plasmatic creatinine
Time Frame: 1 hour before surgery
|
Plasmatic creatinine level measured in mg/dL from a blood sample
|
1 hour before surgery
|
Nerve block performance time
Time Frame: 5 minutes after anesthesia induction (before surgical incision)
|
Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks.
|
5 minutes after anesthesia induction (before surgical incision)
|
Incidence of Block complications
Time Frame: 5 minutes after anesthesia induction and before surgical incision
|
Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms
|
5 minutes after anesthesia induction and before surgical incision
|
Time to first morphine dose request
Time Frame: 24 hours
|
Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device
|
24 hours
|
Morphine consumption during first 48 hours
Time Frame: 48 hours
|
Morphine consumed postoperatively during the first 48 hrs utilizing a patient-controlled analgesia device programmed 0.01mg/Kg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout.
|
48 hours
|
Incidence of opioid related side effects
Time Frame: 48 hours
|
Report of nausea, vomitus, pruritus, urinary retention, respiratory depression
|
48 hours
|
Incidence of NSAIDs related clinical side effects
Time Frame: 48 hours
|
Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma
|
48 hours
|
Postoperative static pain level at 3 hours
Time Frame: 3 hours
|
Pain level measured at rest with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
3 hours
|
Postoperative dynamic pain level at 3 hours
Time Frame: 3 hours
|
Pain level measured during leg extension with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
3 hours
|
Postoperative static pain level at 6 hours
Time Frame: 6 hours
|
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
6 hours
|
Postoperative dynamic pain level at 6 hours
Time Frame: 6 hours
|
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
6 hours
|
Postoperative static pain level at 12 hours
Time Frame: 12 hours
|
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
12 hours
|
Postoperative dynamic pain level at 12 hours
Time Frame: 12 hours
|
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
12 hours
|
Postoperative static pain level at 24 hours
Time Frame: 24 hours
|
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
24 hours
|
Postoperative dynamic pain level at 24 hours
Time Frame: 24 hours
|
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
24 hours
|
Postoperative static pain level at 48 hours
Time Frame: 48 hours
|
Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
48 hours
|
Postoperative dynamic pain level at 48 hours
Time Frame: 48 hours
|
Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain)
|
48 hours
|
Medial malleolus sensory block level
Time Frame: 3 hours
|
0 to 2 points for Sensory block to cold and touch in the medial malleolus.
0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
|
3 hours
|
Lateral malleolus sensory block level
Time Frame: 3hours
|
0 to 2 points for Sensory block to cold and touch in the medial malleolus.
0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
|
3hours
|
Medial malleolus sensory block level
Time Frame: 24 hours
|
0 to 2 points for Sensory block to cold and touch in the medial malleolus.
0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
|
24 hours
|
Lateral malleolus sensory block level
Time Frame: 24 hours
|
0 to 2 points for Sensory block to cold and touch in the medial malleolus.
0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch
|
24 hours
|
Postoperative quadriceps strength
Time Frame: 3 hours
|
Leg extension strength measured with a handheld dynamometer
|
3 hours
|
Postoperative quadriceps strength
Time Frame: 24 hours
|
Leg extension strength measured with a handheld dynamometer
|
24 hours
|
Incidence of restriction to perform physiotherapy
Time Frame: 6 hours
|
Inability to perform physiotherapy secondary to pain or motor blockade
|
6 hours
|
Incidence of restriction to perform physiotherapy
Time Frame: 24 hours
|
Inability to perform physiotherapy secondary to pain or motor blockade
|
24 hours
|
Incidence of restriction to perform physiotherapy
Time Frame: 48 hours
|
Inability to perform physiotherapy secondary to pain or motor blockade
|
48 hours
|
Postoperative plasmatic creatinine level
Time Frame: 48 hours
|
Plasmatic creatinine level measured in mg/dL from a blood sample
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
- Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available.
- Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.
- Aso K, Izumi M, Sugimura N, Okanoue Y, Kamimoto Y, Yokoyama M, Ikeuchi M. Additional benefit of local infiltration of analgesia to femoral nerve block in total knee arthroplasty: double-blind randomized control study. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2368-2374. doi: 10.1007/s00167-018-5322-7. Epub 2018 Dec 8.
- Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.
- Hubbard RC, Naumann TM, Traylor L, Dhadda S. Parecoxib sodium has opioid-sparing effects in patients undergoing total knee arthroplasty under spinal anaesthesia. Br J Anaesth. 2003 Feb;90(2):166-72. doi: 10.1093/bja/aeg038.
- Harris SI, Kuss M, Hubbard RC, Goldstein JL. Upper gastrointestinal safety evaluation of parecoxib sodium, a new parenteral cyclooxygenase-2-specific inhibitor, compared with ketorolac, naproxen, and placebo. Clin Ther. 2001 Sep;23(9):1422-8. doi: 10.1016/s0149-2918(01)80117-x.
- Stoltz RR, Harris SI, Kuss ME, LeComte D, Talwalker S, Dhadda S, Hubbard RC. Upper GI mucosal effects of parecoxib sodium in healthy elderly subjects. Am J Gastroenterol. 2002 Jan;97(1):65-71. doi: 10.1111/j.1572-0241.2002.05265.x.
- Seangleulur A, Vanasbodeekul P, Prapaitrakool S, Worathongchai S, Anothaisintawee T, McEvoy M, Vendittoli PA, Attia J, Thakkinstian A. The efficacy of local infiltration analgesia in the early postoperative period after total knee arthroplasty: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Nov;33(11):816-831. doi: 10.1097/EJA.0000000000000516.
- Affas F, Eksborg S, Wretenberg P, Olofsson C, Stephanson N, Stiller CO. Plasma concentration of ketorolac after local infiltration analgesia in hip arthroplasty. Acta Anaesthesiol Scand. 2014 Oct;58(9):1140-5. doi: 10.1111/aas.12371. Epub 2014 Jul 31.
- Laoruengthana A, Rattanaprichavej P, Reosanguanwong K, Chinwatanawongwan B, Chompoonutprapa P, Pongpirul K. A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty. Knee. 2020 Dec;27(6):1708-1714. doi: 10.1016/j.knee.2020.10.005. Epub 2020 Nov 13.
- Chan E, Howle R, Onwochei D, Desai N. Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Reg Anesth Pain Med. 2021 Sep;46(9):784-805. doi: 10.1136/rapm-2021-102681. Epub 2021 May 14.
- Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
June 8, 2023
First Submitted That Met QC Criteria
June 20, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OAIC1308/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
deidentified data under reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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