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

Universitair Ziekenhuis Brussel

Status and phase: Withdrawn; Phase 4

Conditions: Mastectomy; Lymphedema

Treatments: Procedure: Local Injection Anesthesia; Procedure: SAPB

Study type: Interventional

Funder types: Other

Identifiers

NCT04756791

SAPLIA

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Local infiltration anesthesia

Active Comparator group

Description:

Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.

Treatment:

Procedure: Local Injection Anesthesia

Serratus anterior plane block

Experimental group

Description:

Patients receive a SAPB with ropivacaine placed by anesthesiologist.

Treatment:

Procedure: SAPB