CHU de Quebec - Universite Laval
Québec, Quebec, G1H5B8, Canada
Location status: Recruiting
NCT Number: NCT06276257
Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.
The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Not applicable
Québec, Quebec, G1H5B8, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.
The patient will receive analgesia as per the anesthesiologist's preferences.
Time frame: 24 hours, 28 hours, 72 hours after surgery
Postoperative pain will be measured using the Brief Pain Inventory (BPI)
Time frame: within 3 months after surgery
Total dose of narcotics received intraoperatively (in mg morphine equivalent)
Time frame: During surgery
Analgesics other than opioids used intraoperatively
Time frame: During PACU stay
Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)
Time frame: Within 3 months after surgery
Time to first opioid dose after surgery
Time frame: Within 48 hours after surgery
Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)
Time frame: At 3 months after surgery
Presence of chronic pain at the surgical site at 3 months
Contact information is provided by the study sponsor or research team.
CHU de Quebec-Universite Laval
Other
Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07716566
Neurologic Manifestations, Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07540104
Agnosia, Nervous System Diseases
Atakent, Samsun, Turkey (Türkiye)
View Trial DetailsNCT07458360
Arthritis, Joint Diseases
Konya, Turkey (Türkiye)
View Trial DetailsNCT07426731
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Istanbul, Turkey (Türkiye)
View Trial Details