HysterectomyPhase 3NCT00373464
Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery
A Phase 3 study testing etoricoxib in people with Hysterectomy and Tubal Excision, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Hysterectomy, Tubal Excision, Ovariectomy
- What is being tested?
- etoricoxib
- How many people
- 126 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2006to Mar 2007
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (American Society of Anaesthesiologists [ASA] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
- Written informed consent.
- Weight between 50 and 120 kg.
Who cannot join
- Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
- Sensitivity to the study drug or its components.
- Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
- Cerebrovascular disease.
- Other applicable exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.
Read the detailed description
Postoperative pain can contribute to reduce the patient well-being and, if it is pronounced, delay rehabilitation and increase the total cost for nursing and treatment.
As quite extensive surgical procedures presently are being undertaken on an ambulatory basis the need for adequate post-operative pain prophylaxis is stressed. Pain and nausea/vomiting are the most frequent causes of delayed discharge or unanticipated admission to hospital stay after ambulatory surgery (1). As opioids for postoperative pain relief have a lot of unwanted side-effects (e.g. nausea, vomiting, sleepiness, obstipation, disturbed physiological sleep [2]), it has been shown beneficial, both in terms of cost-effectiveness and patient satisfaction, to reduce the need of opioids in post-operative setting by other means (i.e. non-opioid) methods of pain-relief. The concept of multimodal, non-opioid pain prophylaxis and treatment is being advocated as optimal after ambulatory surgery. The most important modes of non-opioid pain prophylaxis, at present, is paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and local anaesthesia. The best result is achieved when these different modes are used together in a prophylactic manner; the need of rescue opioid analgesics may be reduced by 20-50% and in many cases diminish (3). It has been shown in many studies that the NSAID is an important component in routine post-operative pain prophylaxis, e.g. NSAID in combination with paracetamol provides better analgesic effect than paracetamol alone, and may be equianalgesic to a small-medium dose of opioid (2).
There are four problems with NSAIDs when used for routine pain prophylaxis in ambulatory surgery/anaesthesia: increased bleeding tendency, gastrointestinal ulceration, renal failure and anaphylactic reactions (2-4).
There are definite potential benefits with etoricoxib in ambulatory setting (5-7): Due to cox-II selectivity there is no concern of increased bleeding tendency; thus the drug can be given pre-operatively. It is a potent, oral coxib; thus cheaper and more simple than IV NSAIDs. It has a long duration of effect; thus the need of patient attention is reduced because the first dose lasts for 24 h and a single daily dose will be optimal further on.
It has a lower potential of gastrointestinal ulceration, thus may be used in some patients where conventional NSAIDs may be contraindicated.
It has so far not been shown to have harmful cardiovascular effects in prospective studies of continuous use for at least 12 months in patients with increased risk of cardiovascular complications (ref 8: Edge study).
Study rationale: Etoricoxib has so far been compared with traditional oral NSAIDs and oral coxibs for postoperative pain prophylaxis. However, in many clinical situations the use of pre-operative conventional NSAIDs is not recommended due to the risk of preoperative bleeding. These patients are usually given IV ketorolac during the last part of the procedure as the most efficient alternative for post-operative pain prophylaxis.
It will be of great interest to compare this practice with the use of oral etoricoxib given pre-operatively. If the analgesic quality of an adequate dose etoricoxib is comparable to a ketorolac regimen, the etoricoxib approach will have a lot of potential benefits: simple, cheap, earlier start of analgesia, more longlasting analgesia and less risk of postoperative bleeding and gastrointestinal ulcer. If successful, a single pre-operative dose of etoricoxib may be a routine measure in a majority of all ambulatory surgery patients.
Hypotheses: A single dose pre-operative of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regimen of IV ketorolac 30 mg + 30 mg during the first 18 h( +/- 1 h) after gynaecologic laparoscopic surgical procedure, where the need for post-operative opioid is expected.
Bibliography:
- Chung F, Mezei G: Adverse outcomes in ambulatory anesthesia. Can. J Anaesth. 1999; 46:R18-R34.
- Dahl V, Raeder JC: Non-opioid postoperative analgesia. Acta Anaesthesiol. Scand. 2000; 44:1191-203.
- Dahl V, Raeder JC, Drosdal S, Wathne O, Brynildsrud J: Prophylactic oral ibuprofen or ibuprofen-codeine versus placebo for postoperative pain after primary hip arthroplasty. Acta Anaesthesiol. Scand. 1995; 39:323-6.
- Rawal N: Postoperative pain management in day surgery. Anaesthesia 1998; 53 Suppl. 2: 50-2.
- Chang DJ, Desjardins PJ et al. The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute post-operative pain model. Anest. Analg. 2004; 99; 807-15.
- Cochrane DJ, Jarvis B et al. Etoricoxib. Drugs 2003; 62:2637-51.
- Malmstrøm K, Sapre A et al. Etoricoxib in acute pain associated with dental surgery. Clin. Ther. 2004; 26:667-79.
- The EDGE study: MSD preliminary communication.
- Conditions
- Hysterectomy, Tubal Excision, Ovariectomy, Postoperative Pain
- Being tested
- etoricoxib
- Keywords
- Postoperative pain, Opioid, Etoricoxib, Ketorolac, Laparoscopic Surgery, Surgical Procedures, Gynecologic
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Equal opioid consumption in both groups postoperatively
Secondary outcomes (1)
Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Oslo
- Investigators
- Johan Ræder, Prof.MD,PhD, Study director, Ullevaal University HospitalHarald Lenz, MD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373464
- Sponsor's protocol ID
- 2005-003078-92
- Other IDs
- 2005
- Status last verified
- Aug 2005
- First submitted
- 6 Sep 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids
- ClinicalTrials.gov ID
- NCT00373464
- Acronym / sponsor ID
- 2005-003078-92
- Conditions
- Hysterectomy, Tubal Excision, Ovariectomy, Postoperative Pain
- Keywords
- Postoperative pain, Opioid, Etoricoxib, Ketorolac, Laparoscopic Surgery, Surgical Procedures, Gynecologic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, University of Oslo
- Study start
- Mar 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 8 Sep 2006 (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.
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.
Detailed description
Postoperative pain can contribute to reduce the patient well-being and, if it is pronounced, delay rehabilitation and increase the total cost for nursing and treatment.
As quite extensive surgical procedures presently are being undertaken on an ambulatory basis the need for adequate post-operative pain prophylaxis is stressed. Pain and nausea/vomiting are the most frequent causes of delayed discharge or unanticipated admission to hospital stay after ambulatory surgery (1). As opioids for postoperative pain relief have a lot of unwanted side-effects (e.g. nausea, vomiting, sleepiness, obstipation, disturbed physiological sleep [2]), it has been shown beneficial, both in terms of cost-effectiveness and patient satisfaction, to reduce the need of opioids in post-operative setting by other means (i.e. non-opioid) methods of pain-relief. The concept of multimodal, non-opioid pain prophylaxis and treatment is being advocated as optimal after ambulatory surgery. The most important modes of non-opioid pain prophylaxis, at present, is paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and local anaesthesia. The best result is achieved when these different modes are used together in a prophylactic manner; the need of rescue opioid analgesics may be reduced by 20-50% and in many cases diminish (3). It has been shown in many studies that the NSAID is an important component in routine post-operative pain prophylaxis, e.g. NSAID in combination with paracetamol provides better analgesic effect than paracetamol alone, and may be equianalgesic to a small-medium dose of opioid (2).
There are four problems with NSAIDs when used for routine pain prophylaxis in ambulatory surgery/anaesthesia: increased bleeding tendency, gastrointestinal ulceration, renal failure and anaphylactic reactions (2-4).
There are definite potential benefits with etoricoxib in ambulatory setting (5-7): Due to cox-II selectivity there is no concern of increased bleeding tendency; thus the drug can be given pre-operatively. It is a potent, oral coxib; thus cheaper and more simple than IV NSAIDs. It has a long duration of effect; thus the need of patient attention is reduced because the first dose lasts for 24 h and a single daily dose will be optimal further on.
It has a lower potential of gastrointestinal ulceration, thus may be used in some patients where conventional NSAIDs may be contraindicated.
It has so far not been shown to have harmful cardiovascular effects in prospective studies of continuous use for at least 12 months in patients with increased risk of cardiovascular complications (ref 8: Edge study).
Study rationale: Etoricoxib has so far been compared with traditional oral NSAIDs and oral coxibs for postoperative pain prophylaxis. However, in many clinical situations the use of pre-operative conventional NSAIDs is not recommended due to the risk of preoperative bleeding. These patients are usually given IV ketorolac during the last part of the procedure as the most efficient alternative for post-operative pain prophylaxis.
It will be of great interest to compare this practice with the use of oral etoricoxib given pre-operatively. If the analgesic quality of an adequate dose etoricoxib is comparable to a ketorolac regimen, the etoricoxib approach will have a lot of potential benefits: simple, cheap, earlier start of analgesia, more longlasting analgesia and less risk of postoperative bleeding and gastrointestinal ulcer. If successful, a single pre-operative dose of etoricoxib may be a routine measure in a majority of all ambulatory surgery patients.
Hypotheses: A single dose pre-operative of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regimen of IV ketorolac 30 mg + 30 mg during the first 18 h( +/- 1 h) after gynaecologic laparoscopic surgical procedure, where the need for post-operative opioid is expected.
Bibliography:
- Chung F, Mezei G: Adverse outcomes in ambulatory anesthesia. Can. J Anaesth. 1999; 46:R18-R34.
- Dahl V, Raeder JC: Non-opioid postoperative analgesia. Acta Anaesthesiol. Scand. 2000; 44:1191-203.
- Dahl V, Raeder JC, Drosdal S, Wathne O, Brynildsrud J: Prophylactic oral ibuprofen or ibuprofen-codeine versus placebo for postoperative pain after primary hip arthroplasty. Acta Anaesthesiol. Scand. 1995; 39:323-6.
- Rawal N: Postoperative pain management in day surgery. Anaesthesia 1998; 53 Suppl. 2: 50-2.
- Chang DJ, Desjardins PJ et al. The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute post-operative pain model. Anest. Analg. 2004; 99; 807-15.
- Cochrane DJ, Jarvis B et al. Etoricoxib. Drugs 2003; 62:2637-51.
- Malmstrøm K, Sapre A et al. Etoricoxib in acute pain associated with dental surgery. Clin. Ther. 2004; 26:667-79.
- The EDGE study: MSD preliminary communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (American Society of Anaesthesiologists [ASA] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
- Written informed consent.
- Weight between 50 and 120 kg.
Key exclusion criteria (5 listed)
- Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
- Sensitivity to the study drug or its components.
- Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
- Cerebrovascular disease.
- Other applicable exclusion criteria.
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 |
|---|---|---|
| etoricoxib | Drug | – |
Primary outcome
Equal opioid consumption in both groups postoperatively
1 secondary outcome
Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours
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 1 Jul 2011.
Related trials for Hysterectomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTS OF ULTRASOUND-GUIDED QUADRO-ILIAC PLANE AND TRANSVERSUS ABDOMINIS PLANE BLOCKS IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY
Postoperative Pain Following Total Laparoscopic Hysterectomy
Active, not recruitingPhase 2
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
Post Operative Analgesia
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruiting
Clinical Assessment - HominisTM Surgical System
Hysterectomy
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.
Johan Ræder, Prof.MD,PhD study director
Ullevaal University Hospital
Harald Lenz, MD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing etoricoxib in people with Hysterectomy and Tubal Excision, run by Ullevaal University Hospital at 1 site in Norway.
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 3 inclusion and 5 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 1 Jul 2011. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Equal opioid consumption in both groups postoperatively. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2011.