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

Postoperative Pain Clinical Trial

Official title:

Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534610
• Other study ID #: AN010-13
• Status: Completed
• Phase: N/A
• First received: August 20, 2015
• Last updated: August 26, 2015
• Start date: January 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Foisor Orthopedics Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Romania	Foisor Orthopedics Clinical Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Foisor Orthopedics Clinical Hospital

Country where clinical trial is conducted

Romania, 

References & Publications (7)

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. Review. — View Citation

Dahl JB, Møiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. Print 2004. Review. — View Citation

Derry S, Moore RA. Single dose oral celecoxib for acute postoperative pain in adults. Cochrane Database Syst Rev. 2013 Oct 22;10:CD004233. doi: 10.1002/14651858.CD004233.pub4. Review. — View 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- — View Citation

Møiniche 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3	At 48 hour postoperative	Yes
Secondary	Number of patients with side effects of drugs used	number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions	48 hour postoperative	Yes
Secondary	Duration of analgesia	Time from spinal anesthesia until the first rescue morphine analgesia	At 48 hours postoperative	No