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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04756791
Other study ID # SAPLIA
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 16, 2021
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source Universitair Ziekenhuis Brussel
Contact Evelien Vandeurzen
Phone 192 92 37
Email evelien.vandeurzen@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
SAPB
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Local Injection Anesthesia
Anesthesia is injected directly into the tissue that is will be numbing.

Locations

Country Name City State
Belgium UZ Brussel Jette Brussel

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The use of opioids in the postoperative period 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. 24 hours
Secondary Numerical Pain Rating Scale 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. 24 hours
Secondary Degree of arm mobilization How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization 24 hours
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