Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty
NCT ID: NCT02534610
Last Updated: 2015-08-27
Study Results
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Basic Information
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COMPLETED
NA
165 participants
INTERVENTIONAL
2014-01-31
2014-09-30
Brief Summary
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Detailed Description
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All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with intravenous (IV) Perfalgan and morphine on demand for the following 48 h.
The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS \> 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Etoricoxib
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
Placebo
Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Etoricoxib
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
Placebo
Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Group PLACEBO
1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
Placebo
Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Interventions
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Etoricoxib
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
Placebo
Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* weight (kilos) over 40 kg
* height (centimeters) over 155 cm
* non-anemic
* indication for primary TKA (total knee arthroplasty)
Exclusion Criteria
* peptic ulcer
* severe hepatic or renal dysfunction
* neuropathies
* bleeding disorders
* uncooperative
* drug abuse
* sensibility to etoricoxib
* paracetamol or morphine
* long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days preoperative
* cerebrovascular and peripheric vascular disease
* arterial hypertension (HTA) not adequately controlled
* congestive heart failure.
18 Years
80 Years
ALL
No
Sponsors
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Foisor Orthopedics Clinical Hospital
OTHER
Responsible Party
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Munteanu Ana Maria, MD, PhD
Medical Director
Principal Investigators
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Munteanu Ana-Maria, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Foisor Orthopedics Clinical Hospital Bucharest
Stoica I Cristian, MD, Prof.
Role: STUDY_DIRECTOR
Foisor Orthopedics Clinical Hospital Bucharest
Locations
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Foisor Orthopedics Clinical Hospital
Bucharest, , Romania
Countries
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References
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Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.
Sinatra R. Role of COX-2 inhibitors in the evolution of acute pain management. J Pain Symptom Manage. 2002 Jul;24(1 Suppl):S18-27. doi: 10.1016/s0885-3924(02)00410-4.
Singer MA. Interaction of dibucaine and propranolol with phospholipid bilayer membranes-effect of alterations in fatty acyl composition. Biochem Pharmacol. 1977 Jan 1;26(1):51-7. doi: 10.1016/0006-2952(77)90129-0. No abstract available.
Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
Moiniche S, Kehlet H, Dahl JB. A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia. Anesthesiology. 2002 Mar;96(3):725-41. doi: 10.1097/00000542-200203000-00032. No abstract available.
Lee 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.
Derry S, Moore RA. Single dose oral celecoxib for acute postoperative pain in adults. Cochrane Database Syst Rev. 2013 Oct 22;2013(10):CD004233. doi: 10.1002/14651858.CD004233.pub4.
Munteanu AM, Cionac Florescu S, Anastase DM, Stoica CI. Is there any analgesic benefit from preoperative vs. postoperative administration of etoricoxib in total knee arthroplasty under spinal anaesthesia?: A randomised double-blind placebo-controlled trial. Eur J Anaesthesiol. 2016 Nov;33(11):840-845. doi: 10.1097/EJA.0000000000000521.
Other Identifiers
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AN010-13
Identifier Type: -
Identifier Source: org_study_id
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