Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373464
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2006-09-06
Brief Title:
Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Surgery
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 nauseavomiting 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 eg 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 ie 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 eg 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 surgeryanaesthesia 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
1 Chung F Mezei G Adverse outcomes in ambulatory anesthesia Can J Anaesth 1999 46R18-R34
2 Dahl V Raeder JC Non-opioid postoperative analgesia Acta Anaesthesiol Scand 2000 441191-203
3 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 39323-6
4 Rawal N Postoperative pain management in day surgery Anaesthesia 1998 53 Suppl 2 50-2
5 Chang DJ Desjardins PJ et al The analgesic efficacy of etoricoxib compared with oxycodoneacetaminophen in an acute post-operative pain model Anest Analg 2004 99 807-15
6 Cochrane DJ Jarvis B et al Etoricoxib Drugs 2003 622637-51
7 Malmstrøm K Sapre A et al Etoricoxib in acute pain associated with dental surgery Clin Ther 2004 26667-79
8 The EDGE study MSD preliminary communication
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 nauseavomiting 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 eg 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 ie 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 eg 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 surgeryanaesthesia 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
1 Chung F Mezei G Adverse outcomes in ambulatory anesthesia Can J Anaesth 1999 46R18-R34
2 Dahl V Raeder JC Non-opioid postoperative analgesia Acta Anaesthesiol Scand 2000 441191-203
3 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 39323-6
4 Rawal N Postoperative pain management in day surgery Anaesthesia 1998 53 Suppl 2 50-2
5 Chang DJ Desjardins PJ et al The analgesic efficacy of etoricoxib compared with oxycodoneacetaminophen in an acute post-operative pain model Anest Analg 2004 99 807-15
6 Cochrane DJ Jarvis B et al Etoricoxib Drugs 2003 622637-51
7 Malmstrøm K Sapre A et al Etoricoxib in acute pain associated with dental surgery Clin Ther 2004 26667-79
8 The EDGE study MSD preliminary communication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None