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

NCT02534610 | Completed

• 1 other identifier: AN010-13
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Keywords

preemptive; postoperative pain; etoricoxib

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

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

  At 48 hour postoperative

Secondary Outcomes (2)

• Number of patients with side effects of drugs used

  48 hour postoperative

• Duration of analgesia

  At 48 hours postoperative

Study Arms (3)

Group ETORICOXIB PREOP

EXPERIMENTAL

Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.

Drug: Etoricoxib; Drug: Placebo

Group ETORICOXIB POSTOP

EXPERIMENTAL

Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).

Drug: Etoricoxib; Drug: Placebo

Group PLACEBO

PLACEBO COMPARATOR

1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.

Drug: Placebo

Interventions

Etoricoxib DRUG

120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.

Also known as: Arcoxia, Tauxib, Algix, Exxiv, Etozox

Group ETORICOXIB POSTOP; Group ETORICOXIB PREOP

Placebo DRUG

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.

Also known as: Sham pill

Group ETORICOXIB POSTOP; Group ETORICOXIB PREOP; Group PLACEBO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foisor Orthopedics Clinical Hospital: lead

Study Sites (1)

Foisor Orthopedics Clinical Hospital

Bucharest, 021382, Romania

Location

Related Publications (8)

• 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.

  PMID: 19606021 RESULT

• 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.

  PMID: 12204484 RESULT

• 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.

  PMID: 188426 RESULT

• Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.

  PMID: 15596866 RESULT

• 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.

  PMID: 11873051 RESULT

• 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.

  PMID: 23703420 RESULT

• 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.

  PMID: 24150982 RESULT

• 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.

  PMID: 27454662 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Etoricoxib; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Munteanu Ana-Maria, MD, PhD

  Foisor Orthopedics Clinical Hospital Bucharest

  PRINCIPAL INVESTIGATOR

• Stoica I Cristian, MD, Prof.

  Foisor Orthopedics Clinical Hospital Bucharest

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 27, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

RO (1)