Clinical trial NCT02534610: Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty
Official title: Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: preemptive
postoperative pain
etoricoxib
Lead sponsor: Foisor Orthopedics Clinical Hospital
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).

Detailed description: The investigators conducted a prospective randomized controlled study in 165 patients American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in 3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120 mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal anesthesia.

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.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* weight (kilos) over 40 kg
* height (centimeters) over 155 cm
* non-anemic
* indication for primary TKA (total knee arthroplasty)

Exclusion Criteria:

* history of asthma
* 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.

Primary outcomes:
measure: Total morphine consumption
timeFrame: At 48 hour postoperative
Secondary outcomes:
measure: Number of patients with side effects of drugs used
timeFrame: 48 hour postoperative
measure: Duration of analgesia
timeFrame: At 48 hours postoperative
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Foisor Orthopedics Clinical Hospital
Study officials:
affiliation: Foisor Orthopedics Clinical Hospital Bucharest
name: Munteanu Ana-Maria, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Foisor Orthopedics Clinical Hospital Bucharest
name: Stoica I Cristian, MD, Prof.
role: STUDY_DIRECTOR
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citation: 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.
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citation: 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.