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

Last updated: May 10, 2023
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

4

Condition

Lymphedema

Treatment

Local Injection Anesthesia

SAPB

Clinical Study ID

NCT04756791
SAPLIA
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 scheduledunilat-eral mastectomy.

Exclusion

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 toassess 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

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Local Injection Anesthesia
Phase: 4
Study Start date:
June 16, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • UZ Brussel

    Jette, Brussel 1090
    Belgium

    Active - Recruiting

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