Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163930
Status:
UNKNOWN
Last Update Posted:
2006-10-03
First Post:
2005-09-12
Brief Title:
Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
This project seeks to evaluate the effectiveness of a new post-operative pain relief program for women who have undergone uterine artery embolisation UAE
UAE is performed by an interventional radiologist as a treatment of uterine fibroids non-cancerous growths of the uterus UAE can be associated with a high level of post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for dealing with this acute pain
There will be two treatment groups into which patients will be randomly assigned One will receive the current post-operative therapy dose-on-demand and the other will receive the new therapy pre-emptive dosing Otherwise patients will receive standard management protocol for this procedure Only patients that are scheduled for UAE will be enrolled up to 40 patients
The new treatment involves giving the patient their morphine dose orally and sixty minutes before the procedure begins pre-emptive dosing as opposed to current standard treatment which involves giving the patient a dose of morphine intravenously once they feel pain
Information to be collected directly from patients includes pain and nausea levels indicated on a visual scale a 10 centimetre line showing a spectrum of no pain to worst pain imaginable as well as their opinions of the effectiveness of the pain relief program and the procedure itself This information is to be collected immediately post-procedure and at 2 4 6 and 24 hours post procedure Each VAS will take the patient approximately 20 seconds to complete Information about concurrent medication and procedure complications post-operative vomiting and respiratory depression will be collected from the patients history
UAE is performed by an interventional radiologist as a treatment of uterine fibroids non-cancerous growths of the uterus UAE can be associated with a high level of post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for dealing with this acute pain
There will be two treatment groups into which patients will be randomly assigned One will receive the current post-operative therapy dose-on-demand and the other will receive the new therapy pre-emptive dosing Otherwise patients will receive standard management protocol for this procedure Only patients that are scheduled for UAE will be enrolled up to 40 patients
The new treatment involves giving the patient their morphine dose orally and sixty minutes before the procedure begins pre-emptive dosing as opposed to current standard treatment which involves giving the patient a dose of morphine intravenously once they feel pain
Information to be collected directly from patients includes pain and nausea levels indicated on a visual scale a 10 centimetre line showing a spectrum of no pain to worst pain imaginable as well as their opinions of the effectiveness of the pain relief program and the procedure itself This information is to be collected immediately post-procedure and at 2 4 6 and 24 hours post procedure Each VAS will take the patient approximately 20 seconds to complete Information about concurrent medication and procedure complications post-operative vomiting and respiratory depression will be collected from the patients history
Detailed Description:
Post operative Pain Management in Paitents Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
Protocol Ver 21
11 Research Question Does pre emptive morphine dosing help reduce acute post operative pain as expressed on a visual analogue scale VAS andor post operative opioid use in patients undergoing uterine artery embolisation
21 Enrolment Patients are enrolled by Prof Ken Thomson or Dr Stuart Lyon during a planning consultation with each woman They will be required to sign a consent form if they choose to participate at this point 3 photocopies of this consent form will be taken with one copy to go with the patient the history and the data file
22 Exclusions
Patients with the following should be excluded from the study
Pregnancy
Contrast allergy
Allergy to one or more of the treatment drugs
History of alcoholism
Diagnosed hepatic disease
Renal insufficiency
Acute pelvic infection
Endometrial carcinoma
Undiagnosed pelvic mass
Non English speaking patients
Patients who require post op non opioid analgesia
31 Randomisation and blinding The placebo and oxycontinSR tablets have been pre randomised by the clinical trials pharmacy on LG level Ann Mak
41 Pre medications The trial drug oxycontin will be ordered on a yellow clinical trial prescription form A day before the patient arrives this form should be faxed to the Clinical Trials Pharmacy Fax No 3305 A registered nurse from the ward or researcher should then pick up the drugs from the Clinical Trials Pharmacy on LG level
The other non trial medications should be either already on the ward or should be ordered via pharmacy as per normal
The trial drugs and pre medications will all be written up on a prepared drug chart which will be given to the ward
42 Treatment
The ward staff will administer the drugs as prescribed on the drug chart 60 - 20 minutes prior to the procedure
The differences in the treatment is shown on the following table Dose on demand treatment Pre emptive treatment
1 hour before surgery
Paracetamol 15g
Temazepam 20mg
Placebo OxycontinSR
Piroxicam Feldene 20mg
Ondansetron 8mg 1 hour before surgery
Paracetamol 15g
Temazepam 20mg
OxycontinSR
Piroxicam Feldene 20mg
Ondansetron 8mg
Surgery
PCA morphine
1mg dose with 5 minute lockout Surgery
PCA morphine
1mg dose with 5 minute lockout Follow up
Endone 5-10mg oral 424 prn Follow up
Endone 5-10mg oral 424 prn
The ward staff will be blinded as to which treatment the patient receives since the pre meds are have been randomised and blinded by the pharmacy
51 Post op Pain and nausea measurements will be taken at 2 4 6 and 24 hours using the visual analogue scale VAS questionnaire sheets This can be done either by the researchers or if time permits ward staff
Drug related side effects are also recorded such as respiratory depression and vomiting and it is therefore important for these to be carefully documented in the patients history
52 Deviations from pain management protocol There may be instances where the PCA does not deliver adequate pain relief It may be necessary in these cases to deviate from the pain management protocol for the comfort of the patient This does not necessarily exclude the patient from the study However the way in which the data is interpreted once non opioid analgesia is given should be done with caution
Deviations should be instituted when
Obvious drug related side effects are evident eg respiratory depression narcosis or
Pain is not at an acceptable level at 6 hours post procedure or
Pain is not at a level in keeping with routine post UAE pain as reported by nursing or medical staff
Please notify Dr Stuart Lyon or Dr Jeff Tam ex 3606 if the Pain Team needs to intervene for these patients They will then assess whether or not the patient will be excluded from the study
61 Discharge
When patients are deemed ready for discharge they need to take home a discharge pack with some questionnaires for them to fill out at home These should be done at 24 hours post procedure The pack will include
Pain VAS
Nausea VAS
Overall pain relief rating VAS
UAE procedure rating VAS
Instructions sheet
Reply paid self addressed envelope
Please check that the 2 4 and 6 hour questionnaires have been filled out before the patient is discharged and that they leave with the discharge pack Once completed the questionnaires should be sent back to the Radiology Research Department
Most patients will be discharged within 24 hours of the procedure In the event that the patient stays in hospital longer than 24 hours then the discharge pack should be completed at the 24 hour mark The completed data sheets should then be sent back to the Radiology Research Department
If the data sheets are not received within 2 weeks of discharge the researchers should make a phone call to the patient to enquire whether they have been completed and to answer any questions the patient may have
Protocol Ver 21
11 Research Question Does pre emptive morphine dosing help reduce acute post operative pain as expressed on a visual analogue scale VAS andor post operative opioid use in patients undergoing uterine artery embolisation
21 Enrolment Patients are enrolled by Prof Ken Thomson or Dr Stuart Lyon during a planning consultation with each woman They will be required to sign a consent form if they choose to participate at this point 3 photocopies of this consent form will be taken with one copy to go with the patient the history and the data file
22 Exclusions
Patients with the following should be excluded from the study
Pregnancy
Contrast allergy
Allergy to one or more of the treatment drugs
History of alcoholism
Diagnosed hepatic disease
Renal insufficiency
Acute pelvic infection
Endometrial carcinoma
Undiagnosed pelvic mass
Non English speaking patients
Patients who require post op non opioid analgesia
31 Randomisation and blinding The placebo and oxycontinSR tablets have been pre randomised by the clinical trials pharmacy on LG level Ann Mak
41 Pre medications The trial drug oxycontin will be ordered on a yellow clinical trial prescription form A day before the patient arrives this form should be faxed to the Clinical Trials Pharmacy Fax No 3305 A registered nurse from the ward or researcher should then pick up the drugs from the Clinical Trials Pharmacy on LG level
The other non trial medications should be either already on the ward or should be ordered via pharmacy as per normal
The trial drugs and pre medications will all be written up on a prepared drug chart which will be given to the ward
42 Treatment
The ward staff will administer the drugs as prescribed on the drug chart 60 - 20 minutes prior to the procedure
The differences in the treatment is shown on the following table Dose on demand treatment Pre emptive treatment
1 hour before surgery
Paracetamol 15g
Temazepam 20mg
Placebo OxycontinSR
Piroxicam Feldene 20mg
Ondansetron 8mg 1 hour before surgery
Paracetamol 15g
Temazepam 20mg
OxycontinSR
Piroxicam Feldene 20mg
Ondansetron 8mg
Surgery
PCA morphine
1mg dose with 5 minute lockout Surgery
PCA morphine
1mg dose with 5 minute lockout Follow up
Endone 5-10mg oral 424 prn Follow up
Endone 5-10mg oral 424 prn
The ward staff will be blinded as to which treatment the patient receives since the pre meds are have been randomised and blinded by the pharmacy
51 Post op Pain and nausea measurements will be taken at 2 4 6 and 24 hours using the visual analogue scale VAS questionnaire sheets This can be done either by the researchers or if time permits ward staff
Drug related side effects are also recorded such as respiratory depression and vomiting and it is therefore important for these to be carefully documented in the patients history
52 Deviations from pain management protocol There may be instances where the PCA does not deliver adequate pain relief It may be necessary in these cases to deviate from the pain management protocol for the comfort of the patient This does not necessarily exclude the patient from the study However the way in which the data is interpreted once non opioid analgesia is given should be done with caution
Deviations should be instituted when
Obvious drug related side effects are evident eg respiratory depression narcosis or
Pain is not at an acceptable level at 6 hours post procedure or
Pain is not at a level in keeping with routine post UAE pain as reported by nursing or medical staff
Please notify Dr Stuart Lyon or Dr Jeff Tam ex 3606 if the Pain Team needs to intervene for these patients They will then assess whether or not the patient will be excluded from the study
61 Discharge
When patients are deemed ready for discharge they need to take home a discharge pack with some questionnaires for them to fill out at home These should be done at 24 hours post procedure The pack will include
Pain VAS
Nausea VAS
Overall pain relief rating VAS
UAE procedure rating VAS
Instructions sheet
Reply paid self addressed envelope
Please check that the 2 4 and 6 hour questionnaires have been filled out before the patient is discharged and that they leave with the discharge pack Once completed the questionnaires should be sent back to the Radiology Research Department
Most patients will be discharged within 24 hours of the procedure In the event that the patient stays in hospital longer than 24 hours then the discharge pack should be completed at the 24 hour mark The completed data sheets should then be sent back to the Radiology Research Department
If the data sheets are not received within 2 weeks of discharge the researchers should make a phone call to the patient to enquire whether they have been completed and to answer any questions the patient may have
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