Ignite Creation Date:
2024-05-05 @ 11:22 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01314144
Status:
UNKNOWN
Last Update Posted:
2011-03-14
First Post:
2011-03-11
Brief Title:
Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery
Sponsor:
Cork University Hospital
Organization:
Cork University Hospital
Study Overview
Official Title:
Does Continuous Wound Infusion of 02 Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary Clearance Surgery
Status:
UNKNOWN
Status Verified Date:
2011-03
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:
Axillary clearance forms part of the surgical armamentarium for the treatment of breast cancer Although the introduction of sentinel lymph node mapping and dissection has allowed for the decreased use of axillary clearance it remains a frequently performed operation Axillary clearance is associated with moderate postoperative pain
We hypothesize that a continuous wound infusion of 02 Bupivacaine at 4mlhr would provide superior analgesia when compared to standard opioid-based analgesia in patients undergoing axillary lymph node clearance surgery
We hypothesize that a continuous wound infusion of 02 Bupivacaine at 4mlhr would provide superior analgesia when compared to standard opioid-based analgesia in patients undergoing axillary lymph node clearance surgery
Detailed Description:
The study will take the form of a prospective randomised clinical trial The following assessment tools will be used
The visual analogue scale VAS consists of a 100 mm horizontal line with the two end points labelled no pain and worst pain ever Patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel The score is obtained by measuring the distance mm from the left end of the line
The short-form McGill Pain Questionnaire SF-MPQ consists of 15 representative words from the sensory and affective categories of the standard McGill Pain Questionnaire It also includes the present pain intensity and a VAS to provide overall indices of pain intensity It has been shown to be sensitive to clinical changes brought about by various interventions postoperative analgesic drugs 6
The Pain Catastrophising Score PCS is a 13 item instrument which asks patient to reflect on past painful experiences and to indicate the degree to which they experienced each of these 13 thoughts or feelings on 5-point scales with the end points 0 not at all 4 all the time The PCS yields a total score and three subscale scores assessing rumination magnification and helplessness 7
The Hospital Anxiety and Depression Score HADS is a 14-item scale which screens for these the two most common disturbances encountered in a medical setting 8
The visual analogue scale VAS consists of a 100 mm horizontal line with the two end points labelled no pain and worst pain ever Patients are asked to mark on the line a point that corresponds to the level of pain intensity they feel The score is obtained by measuring the distance mm from the left end of the line
The short-form McGill Pain Questionnaire SF-MPQ consists of 15 representative words from the sensory and affective categories of the standard McGill Pain Questionnaire It also includes the present pain intensity and a VAS to provide overall indices of pain intensity It has been shown to be sensitive to clinical changes brought about by various interventions postoperative analgesic drugs 6
The Pain Catastrophising Score PCS is a 13 item instrument which asks patient to reflect on past painful experiences and to indicate the degree to which they experienced each of these 13 thoughts or feelings on 5-point scales with the end points 0 not at all 4 all the time The PCS yields a total score and three subscale scores assessing rumination magnification and helplessness 7
The Hospital Anxiety and Depression Score HADS is a 14-item scale which screens for these the two most common disturbances encountered in a medical setting 8
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