Postoperative PainNCT02534610
Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty
A study testing Etoricoxib in people with Postoperative Pain, run by Foisor Orthopedics Clinical Hospital at 1 site in Romania.
Trial summary
Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- weight (kilos) over 40 kg
- height (centimeters) over 155 cm
- non-anemic
- indication for primary TKA (total knee arthroplasty)
Who cannot join
- history of asthma
- peptic ulcer
- severe hepatic or renal dysfunction
- neuropathies
- bleeding disorders
- uncooperative
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Etoricoxib, Placebo
- Keywords
- preemptive, postoperative pain, etoricoxib
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called Arcoxia, Tauxib, Algix, Exxiv
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
PlaceboDrug
Also called Sham pill
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.
| Study group | Role | What they receive |
|---|---|---|
| Group ETORICOXIB PREOP | Experimental | Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery. Receives: 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
Measured: At 48 hour postoperative
Secondary outcomes (2)
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
Measured: 48 hour postoperative
Duration of analgesia
Time from spinal anesthesia until the first rescue morphine analgesia
Measured: At 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foisor Orthopedics Clinical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital
- Investigators
- Munteanu Ana-Maria, MD, PhD, Principal investigator, Foisor Orthopedics Clinical Hospital BucharestStoica I Cristian, MD, Prof., Study director, Foisor Orthopedics Clinical Hospital Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534610
- Sponsor's protocol ID
- AN010-13
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19606021Sinatra 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.
PubMed 12204484Singer 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.
PubMed 188426Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
PubMed 15596866Moiniche 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.
PubMed 11873051Lee 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.
PubMed 23703420Derry 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.
PubMed 24150982Munteanu 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.
PubMed 27454662
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?
- ClinicalTrials.gov ID
- NCT02534610
- Acronym / sponsor ID
- AN010-13
- Conditions
- Postoperative Pain
- Keywords
- preemptive, postoperative pain, etoricoxib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Foisor Orthopedics Clinical HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group ETORICOXIB PREOP | Experimental | Drug: Etoricoxib, Drug: PlaceboPreoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery. |
| Group ETORICOXIB POSTOP | Experimental | Drug: Etoricoxib, Drug: PlaceboPreoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia). |
| Group PLACEBO | Placebo comparator | Drug: Placebo1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-III
- weight (kilos) over 40 kg
- height (centimeters) over 155 cm
- non-anemic
- indication for primary TKA (total knee arthroplasty)
Key exclusion criteria (13 listed)
- history of asthma
- peptic ulcer
- severe hepatic or renal dysfunction
- neuropathies
- bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtoricoxibAlso: Arcoxia, Tauxib, Algix, Exxiv120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery. | Drug | Group ETORICOXIB POSTOP, Group ETORICOXIB PREOP |
| PlaceboAlso: Sham pillGroup 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. | Drug | Group ETORICOXIB POSTOP, Group ETORICOXIB PREOP, Group PLACEBO |
Primary outcome
Total morphine consumption
Time frame: At 48 hour postoperative
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
2 secondary outcomes
Number of patients with side effects of drugs used
Time frame: 48 hour postoperative
Duration of analgesia
Time frame: At 48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- Results publication: PubMed 19606021Buvanendran 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 publication: PubMed 12204484Sinatra 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 publication: PubMed 188426Singer 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 publication: PubMed 15596866Dahl JB, Moiniche S. Pre-emptive analgesia. Br Med Bull. 2004 Dec 13;71:13-27. doi: 10.1093/bmb/ldh030. Print 2004.
- Results publication: PubMed 11873051Moiniche 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 publication: PubMed 23703420Lee 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 publication: PubMed 24150982Derry 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.
- Derived from this study: PubMed 27454662Munteanu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munteanu Ana-Maria, MD, PhD principal investigator
Foisor Orthopedics Clinical Hospital Bucharest
Stoica I Cristian, MD, Prof. study director
Foisor Orthopedics Clinical Hospital Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etoricoxib in people with Postoperative Pain, run by Foisor Orthopedics Clinical Hospital at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: At 48 hour postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534610, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.