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Status unknownNCT04606836Updated Dec 9, 2020

ICNBs for Post-op Pain in Breast Surgery

A Phase 4 interventional study of Bupivacaine Hydrochloride in Pain, Postoperative and Length of Stay, sponsored by Christine M. Kleinert Institute for Hand and Microsurgery. Status unknown at 5 sites in United States. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-09.

Sponsored by Christine M. Kleinert Institute for Hand and Microsurgery · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pain, Postoperative
  • Length of Stay

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Keywords

  • ICNB
  • pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Christine M. Kleinert Institute for Hand and Microsurgery is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Prospective Cases

    These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s).

    Drug: Bupivacaine Hydrochloride

  • No intervention
    Retrospective Controls

    Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.

Interventions

  • DrugBupivacaine Hydrochloride

    See group descriptions

    Also known as: Marcaine

06

What researchers measure

Primary outcomes

  1. Post-operative pain

    Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

    Time frame: Immediately post-operation

  2. Post-operative pain

    Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

    Time frame: 30 minutes post-operation

  3. Post-operative pain

    Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

    Time frame: 60 minutes post-operation

  4. Post-operative pain

    Visual Analog Score (VAS) for pain compared between cases and controls, pain score on scale from 0 (no pain) to 10 (worst pain)

    Time frame: 120 minutes post-operation

Secondary outcomes

  1. Length of Hospital Stay

    time of discharge compared with time of surgery completion; Measured in number of days spent in hospital, i.e., 1 day

    Time frame: Through study completion, average of 1 day

07

Study locations

5 of 5 sites recruiting
  • Ambulatory Surgery Center, Kleinert Kutz Hand Care Center
    New Albany, Indiana 47150, United States
    • Michelle Palazzo, MD · Contact · mpalazzo@kleinertkutz.com
    • Michelle Palazzo, MD · Principal investigator
    • Uzair Qazi, MD · Sub investigator
    • Rehan Zahid, MD · Sub investigator
    Recruiting
  • Baptist Health Floyd
    New Albany, Indiana 47150, United States
    • Michelle Palazzo, MD · Contact · mpalazzo@kleinertkutz.com
    • Michelle Palazzo, MD · Principal investigator
    • Uzair Qazi, MD · Sub investigator
    • Rehan Zahid, MD · Sub investigator
    Recruiting
  • Christine M Kleinert Institute for Hand and Microsurgery
    Louisville, Kentucky 40202, United States
    • Michelle Palazzo, MD · Contact · mpalazzo@kleinertkutz.com
    • Julianne Sutton, MPH · Contact · jsutton@kleinertkutz.com · 5025620390
    • Uzair Qazi, MD · Sub investigator
    • Rehan Zahid, MD · Sub investigator
    • Michelle Palazzo, MD · Principal investigator
    Recruiting
  • HCCOC, Jewish Hospital
    Louisville, Kentucky 40202, United States
    • Michelle Palazzo, MD · Contact · mpalazzo@kleinertkutz.com
    • Uzair Qazi, MD · Sub investigator
    • Michelle Palazzo, MD · Principal investigator
    • Rehan Zahid, MD · Sub investigator
    Recruiting
  • Baptist Health Louisville
    Louisville, Kentucky 40207, United States
    • Michelle Palazzo, MD · Contact · mpalazzo@kleinertkutz.com
    • Michelle Palazzo, MD · Principal investigator
    • Uzair Qazi, MD · Sub investigator
    • Rehan Zahid, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32629834 ↗

Individual participant data

Plan to share: No — Only those researchers involved with the trial will have access to the individual participant data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04606836
Lead sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators
Jewish Hospital and St. Mary's Healthcare, Baptist Health, Kleinert, Kutz and Associates
Responsible party
Sponsor
First posted
Oct 28, 2020
Start date
Dec 7, 2020
Primary completion
Apr 2021 (estimated)
Completion
Aug 2021 (estimated)
Last update
Dec 9, 2020

Study contacts

Julianne Sutton, MPH
Contact
jsutton@klienertkutz.com
5025620390
Michelle Palazzo, MD
principal investigator · Christine M. Kleinert Institute for Hand and Microsurgery

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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