Anesthesia Clinical Trial
Official title:
Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence.
Verified date | May 2021 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is no consensus regarding which alternative is the best anesthesia for breast surgery, general anesthesia and morphine for postoperative analgesia or a combination of regional anesthesia and general anesthesia that possibly attenuates or abolishes the need for morphine. The current study aims to determine which of the two strategies that is best in relation to postoperative pain, nausea and risk of recurrence of the disease.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 22, 2020 |
Est. primary completion date | October 22, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Unilateral surgery on the breast because of suspected malign disease. Exclusion Criteria: Bilateral surgery Metastases other than in the axilla Body Mass Index (BMI) > 35 Not able to communicate in Swedish Dementia American Society of Anesthesiology (ASA) 4 or 5 Chronic pain treatment (use of opiates or medicine for neuropathic pain > 7 days the last month) Known allergy to Morphine or Ropivacaine Congestive Heart Failure, New York Heart Association (NYHA) IIIB or worse Chronic renal failure (S-creatinine increased) Immunosuppression (more than 10 mg daily of Prednisolone or stronger medication) No axillary exploration planned |
Country | Name | City | State |
---|---|---|---|
Sweden | Östersund Hospital | Östersund | Jämtland |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opiate consumption | The cumulative consumption of opiates (Morphine). This is the most often used way to asses the efficacy of the regional anesthesia that the intervention consists of. | 48 hours | |
Primary | All cause mortality | This is to investigate the possible effect that a regional anesthesia may have on recurrence of a malignant tumor. | 3 years and 5 years. | |
Secondary | Postoperative Nausea and Vomiting (PONV) | PONV is common after general anesthesia and more so if opiates are used for analgesia. Measured on an ordinal scale 0=no PONV, 1=nausea, 2=vomiting, 3=repeated vomiting | 48 hours | |
Secondary | Actual pain score | To see if patients with a regional anesthesia have more or less pain than patients with intravenous Morphine as postoperative analgesia. | 48 hours | |
Secondary | Recurrence of breast neoplasm | Recurrence of breast neoplasm | 3 and 5 years | |
Secondary | Chronic Pain | Pain after 6 months as assessed in a telephone interview, measured as Numeric Rate Scale (0-10). | 6 (5-7) months after surgery |
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