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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Etoricoxib
Placebo
Sponsored by
Foisor Orthopedics Clinical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring preemptive, postoperative pain, etoricoxib

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Foisor Orthopedics Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group ETORICOXIB PREOP

Group ETORICOXIB POSTOP

Group PLACEBO

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Duration of analgesia
Time from spinal anesthesia until the first rescue morphine analgesia

Full Information

First Posted
August 20, 2015
Last Updated
August 26, 2015
Sponsor
Foisor Orthopedics Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02534610
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foisor Orthopedics Clinical Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
preemptive, postoperative pain, etoricoxib

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ETORICOXIB PREOP
Arm Type
Experimental
Arm Description
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Arm Title
Group ETORICOXIB POSTOP
Arm Type
Experimental
Arm Description
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Arm Title
Group PLACEBO
Arm Type
Placebo Comparator
Arm Description
1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia, Tauxib, Algix, Exxiv, Etozox
Intervention Description
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sham pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
Time Frame
At 48 hour postoperative
Secondary Outcome Measure Information:
Title
Number of patients with side effects of drugs used
Description
number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions
Time Frame
48 hour postoperative
Title
Duration of analgesia
Description
Time from spinal anesthesia until the first rescue morphine analgesia
Time Frame
At 48 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Munteanu Ana-Maria, MD, PhD
Organizational Affiliation
Foisor Orthopedics Clinical Hospital Bucharest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stoica I Cristian, MD, Prof.
Organizational Affiliation
Foisor Orthopedics Clinical Hospital Bucharest
Official's Role
Study Director
Facility Information:
Facility Name
Foisor Orthopedics Clinical Hospital
City
Bucharest
ZIP/Postal Code
021382
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
19606021
Citation
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.
Results Reference
result
PubMed Identifier
12204484
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. doi: 10.1016/s0885-3924(02)00410-4.
Results Reference
result
PubMed Identifier
188426
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. doi: 10.1016/0006-2952(77)90129-0. No abstract available.
Results Reference
result
PubMed Identifier
15596866
Citation
Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
Results Reference
result
PubMed Identifier
11873051
Citation
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.
Results Reference
result
PubMed Identifier
23703420
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.
Results Reference
result
PubMed Identifier
24150982
Citation
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.
Results Reference
result
PubMed Identifier
27454662
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.
Results Reference
derived

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

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