Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304850
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2006-03-17
Brief Title:
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
Status:
COMPLETED
Status Verified Date:
2009-12
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:
PoLyDOL
Brief Summary:
After surgery sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain It has been shown that N-methyl-D-aspartate NMDA receptors antagonist such as ketamine prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy Polyamines putrescine spermidine spermine are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors In animal studies polyamine-free diet has confirmed these antinociceptive properties This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine
Detailed Description:
This multicentric single blind study will enrol 160 women 18-75 years old operated on tumorectomy and adenectomy T1 T2 T3 N0 N1 M0 for breast cancer Patients will be randomly assigned in a 2x2 factorial plan Group 1 control n 40 group 2 ketamine group administered during and 48 hours after a standardized anesthesia n 40 group 3 polyamine-free diet 1 week and 72 hours after surgery n 40 group 4 ketamine polyamine-free diet n 40
The amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score allodynia Von Frey filaments and hyperalgesia algometer Chronic pain occurrence post-mastectomy pain syndrome will be evaluated at 3 and 6 months using adequate questionnaire analgesic scale Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood
Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared isobolographic method Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic orthopaedic and abdominal surgery In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery
The amount of morphine for the 24 first postoperative hours will be compared between each group as well as pain score allodynia Von Frey filaments and hyperalgesia algometer Chronic pain occurrence post-mastectomy pain syndrome will be evaluated at 3 and 6 months using adequate questionnaire analgesic scale Diet observance will be controlled preoperatively by a dosage of polyamines in circulating red cells blood
Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared isobolographic method Anti-hyperalgesic properties of ketamine have already been demonstrated in urologic orthopaedic and abdominal surgery In case of additive or synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve better postoperative rehabilitation in reducing chronic pain after surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2002-004 | None | None | None |