Clinical trial NCT04606836: ICNBs for Post-op Pain in Breast Surgery
Official title: Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Length of Stay
Keywords: ICNB
pain
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
Collaborators: name: Jewish Hospital and St. Mary's Healthcare
name: Baptist Health
name: Kleinert, Kutz and Associates
First posted: 2020-10-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cases will be recruited prospectively and controls will be taken retrospectively
Primary purpose: PREVENTION

Brief summary: The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Classification (ASA Class) 3 and below.
* Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (\<200 gm), breast augmentation and breast reduction, etc.

Exclusion Criteria:

* Patients who refuse local anesthesia.
* Patients who cannot receive local anesthesia.
* Below the age of 20 and above the age of 70.
* Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
* Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.

Primary outcomes:
measure: Post-operative pain
timeFrame: Immediately post-operation
measure: Post-operative pain
timeFrame: 30 minutes post-operation
measure: Post-operative pain
timeFrame: 60 minutes post-operation
measure: Post-operative pain
timeFrame: 120 minutes post-operation
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Through study completion, average of 1 day
Other outcomes:
Locations:
city: New Albany
country: United States
facility: Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
state: Indiana
city: New Albany
country: United States
facility: Baptist Health Floyd
state: Indiana
city: Louisville
country: United States
facility: Christine M Kleinert Institute for Hand and Microsurgery
state: Kentucky
city: Louisville
country: United States
facility: HCCOC, Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health Louisville
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Michelle Palazzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JW, Kim JH, Woo KJ. Intraoperative Intercostal Nerve Block for Postoperative Pain Control in Pre-Pectoral versus Subpectoral Direct-to-Implant Breast Reconstruction: A Retrospective Study. Medicina (Kaunas). 2020 Jun 30;56(7):325. doi: 10.3390/medicina56070325.