Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Total morphine consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Intervention: Etoricoxib (Drug)
Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Intervention: Placebo (Drug)
Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Intervention: Etoricoxib (Drug)
Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Intervention: Placebo (Drug)
Group PLACEBO
1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Total morphine consumption
Time Frame: At 48 hour postoperative
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
Secondary Outcomes
- Number of patients with side effects of drugs used(48 hour postoperative)
- Duration of analgesia(At 48 hours postoperative)
Investigators
Munteanu Ana Maria, MD, PhD
Medical Director
Foisor Orthopedics Clinical Hospital