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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04586751
Other study ID # Breast-Nektaria
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date March 31, 2022

Study information

Verified date February 2023
Source Aretaieion University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Intervention

Other:
Pecs block
Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.
no Pecs block
no regional block will be performed in this arm

Locations

Country Name City State
Cyprus General Hospital of Limassol Limassol
Cyprus General Hospital of Nicosia Nicosia
Greece Aretaieion University Hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Countries where clinical trial is conducted

Cyprus,  Greece, 

References & Publications (7)

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Outcome

Type Measure Description Time frame Safety issue
Primary pain score 6 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 6 hours after surgery
Primary pain score 12 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 12 hours after surgery
Primary pain score 24 hours postoperatively pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable" 24 hours after surgery
Secondary incidence of chronic pain occurrence of chronic pain at the site of the operation 3 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement 3 months after surgery
Secondary incidence of chronic pain occurrence of chronic pain at the site of the operation 6 months after surgery, with the use of the Numeric Rating Scale (NRS), at rest and during movement 6 months after surgery
Secondary time of first request for analgesia time of first request for analgesia after the operation 24 hours postoperatively
Secondary analgesic consumption in mg of morphine additional analgesic consumption in the first 24 hours after the operation 24 hours postoperatively
Secondary satisfaction from postoperative analgesia satisfaction from postoperative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction 24 hours postoperatively
Secondary Pecs block related complications Pecs block-related complications at the site of the local anesthetic injection 48 hours postoperatively
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