Mastectomy; Lymphedema
Conditions
Brief summary
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Detailed description
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy. Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization. There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.
Interventions
PROCEDURESAPB
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
PROCEDURELocal Injection Anesthesia
Anesthesia is injected directly into the tissue that is will be numbing.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years. * Provision of signed informed consent prior to any study-specific procedure. * Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.
Exclusion criteria
* Age \>80 years * History of chronic pain or drug treatment abuse * Depression, psychiatric morbidity or mal-adaptive coping behavior * Neuropathy * Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain * Chronic or acute skin infection of the lateral thorax * Hypersensitivity to ropivacaine * Severe hepatic or renal disease * Refuse to participate to the study * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The use of opioids in the postoperative period | 24 hours | Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale | 24 hours | Patients will be asked at 4 different time points the amount of pain they are feeling on a scale of 0 to 10. 0 meaning no pain and 10 meaning the worst pain imaginable. |
| Degree of arm mobilization | 24 hours | How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization |
Countries
Belgium
Outcome results
None listed