Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Mastectomy; Lymphedema
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- The use of opioids in the postoperative period
- Status
- Withdrawn
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The use of opioids in the postoperative period
Time Frame: 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 Outcomes
- Numerical Pain Rating Scale(24 hours)
- Degree of arm mobilization(24 hours)