Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty

• Sponsor: Foisor Orthopedics Clinical Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02534610
• Collaborator: (none)
• Enrollment: 165
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 20.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Etoricoxib; Drug: Placebo	N/A

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
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group ETORICOXIB PREOP Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.	Drug: 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.; Other Names: Arcoxia Tauxib Algix Exxiv Etozox ; Drug: 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 Names: Sham pill
Experimental: Group ETORICOXIB POSTOP Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).	Drug: 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.; Other Names: Arcoxia Tauxib Algix Exxiv Etozox ; Drug: 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 Names: Sham pill
Placebo Comparator: Group PLACEBO 1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.	Drug: 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 Names: Sham pill

Outcome Measures

Primary Outcome Measures

1. Total morphine consumption [At 48 hour postoperative]

   Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

Secondary Outcome Measures

1. Number of patients with side effects of drugs used [48 hour postoperative]

   number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions

2. Duration of analgesia [At 48 hours postoperative]

   Time from spinal anesthesia until the first rescue morphine analgesia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foisor Orthopedics Clinical Hospital	Bucharest		Romania	021382

Sponsors and Collaborators

• Foisor Orthopedics Clinical Hospital

Investigators

• Principal Investigator: Munteanu Ana-Maria, MD, PhD, Foisor Orthopedics Clinical Hospital Bucharest
• Study Director: Stoica I Cristian, MD, Prof., Foisor Orthopedics Clinical Hospital Bucharest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Munteanu Ana Maria, MD, PhD, Medical Director, Foisor Orthopedics Clinical Hospital
• ClinicalTrials.gov Identifier: NCT02534610
• Other Study ID Numbers: AN010-13
• First Posted: Aug 27, 2015
• Last Update Posted: Aug 27, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Munteanu Ana Maria, MD, PhD, Medical Director, Foisor Orthopedics Clinical Hospital: preemptive; postoperative pain; etoricoxib
• Additional relevant MeSH terms: Pain, Postoperative; Etoricoxib

Study Results

No Results Posted as of Aug 27, 2015