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ICNBs for Post-op Pain in Breast Surgery

Analyzing the Efficacy of Peri-operative Intercostal Nerve Blocks ICNB for Acute Postoperative Pain Control in Reconstructive Breast Surgery and Mammoplasty

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04606836
Enrollment
40
Registered
2020-10-28
Start date
2020-12-07
Completion date
2021-08-31
Last updated
2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Stay, Pain, Postoperative

Keywords

ICNB, pain

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.

Interventions

DRUGBupivacaine Hydrochloride

See group descriptions

Sponsors

Jewish Hospital and St. Mary's Healthcare
CollaboratorOTHER
Baptist Health
CollaboratorUNKNOWN
Kleinert, Kutz and Associates
CollaboratorOTHER
Christine M. Kleinert Institute for Hand and Microsurgery
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The statistician will be masked to the groups the participants fall in (case vs control).

Intervention model description

Cases will be recruited prospectively and controls will be taken retrospectively

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative painImmediately post-operationVisual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

Secondary

MeasureTime frameDescription
Length of Hospital StayThrough study completion, average of 1 daytime of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day

Countries

United States

Contacts

Primary ContactJulianne Sutton, MPH
jsutton@klienertkutz.com5025620390

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026