Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586751
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-10-06
Brief Title:
The Impact of Pecs Blocks on Postmastectomy Pain Syndrome
Sponsor:
Aretaieion University Hospital
Organization:
Aretaieion University Hospital
Study Overview
Official Title:
The Impact of Pecs Blocks on the Appearance of Post Mastectomy Chronic Pain Symptoms
Status:
COMPLETED
Status Verified Date:
2023-02
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 the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms
Detailed Description:
Breast cancer is the commonest type of malignancy in women Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage usually 3-6 months post-operatively Chronic post-operative pain syndrome of any magnitude usually involves 19-57 of patients that have undergone any kind of surgical procedure while 5 of them experience intense symptoms Risk factors for developing post-mastectomy pain syndrome include younger age increased Body mass Index BMI psychological profile co-existence of other painful conditions pre-operative radiotherapychemotherapy type of surgical procedure and anaesthesia persistent acute postoperative pain etc Consequently chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients
The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms
During the preoperative visit the women will be informed about the study and will be instructed to the use of the pain numeric rating scale NRS graded from 0 to 10 Standardized anesthesia will be administered All patients will receive 1000 mg of paracetamol and 007 mg Kg of morphine intraoperatively In the Post-Anesthesia Care Unit PACU patients will receive additional morphine boluses on request until NRS score is lesser or equal than 4 Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv After discharge from PACU patients will receive a combination of paracetamol 1 gr6h and im pethidine 75 mg on request as per hospital protocol
Numerical rating scores NRS at rest and movement will be measured at 6h 12h and 24h postoperatively Additionally the time to first request for analgesia after surgery will be noted
All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally via the use of Douleur Neuropathique DN4 questionnaire for the occurence of neuropathic pain
The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms
During the preoperative visit the women will be informed about the study and will be instructed to the use of the pain numeric rating scale NRS graded from 0 to 10 Standardized anesthesia will be administered All patients will receive 1000 mg of paracetamol and 007 mg Kg of morphine intraoperatively In the Post-Anesthesia Care Unit PACU patients will receive additional morphine boluses on request until NRS score is lesser or equal than 4 Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv After discharge from PACU patients will receive a combination of paracetamol 1 gr6h and im pethidine 75 mg on request as per hospital protocol
Numerical rating scores NRS at rest and movement will be measured at 6h 12h and 24h postoperatively Additionally the time to first request for analgesia after surgery will be noted
All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally via the use of Douleur Neuropathique DN4 questionnaire for the occurence of neuropathic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None