Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery

Mastectomy; Lymphedema Clinical Trial

— SAPLIA  

Official title:

Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04756791
• Other study ID #: SAPLIA
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Lymphedema
• Mastectomy; Lymphedema

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