Recruiting

ICNBs

Sponsor:

Christine M. Kleinert Institute for Hand and Microsurgery

Code:

NCT04606836

Conditions

Pain, Postoperative

Length of Stay

Eligibility Criteria

Sex: Female

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Bupivacaine Hydrochloride

Study Details

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.

Conditions

Pain, Postoperative

Length of Stay

Study ID

NCT04606836

Start date

Dec 7, 2020

Status verified date

Dec, 2020

Completion date

Aug, 2021

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 20 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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).

no intervention: Retrospective Controls

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

Interventions

Bupivacaine Hydrochloride

See group descriptions

Primary outcome measure

  • Post-operative pain [ Time Frame: Immediately post-operation ]
  • Post-operative pain [ Time Frame: 30 minutes post-operation ]
  • Post-operative pain [ Time Frame: 60 minutes post-operation ]
  • Post-operative pain [ Time Frame: 120 minutes post-operation ]

Central Contacts and Locations

Central contacts

Julianne Sutton, MPH

5025620390jsutton@klienertkutz.com

Locations

Ambulatory Surgery Center, Kleinert Kutz Hand Care Center

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Michelle Palazzo, MD

mpalazzo@kleinertkutz.com

Principal Investigator:

Michelle Palazzo, MD

Baptist Health Floyd

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Michelle Palazzo, MD

mpalazzo@kleinertkutz.com

Principal Investigator:

Michelle Palazzo, MD

Christine M Kleinert Institute for Hand and Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Michelle Palazzo, MD

mpalazzo@kleinertkutz.com

Julianne Sutton, MPH

5025620390jsutton@kleinertkutz.com

Principal Investigator:

Michelle Palazzo, MD

HCCOC, Jewish Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Michelle Palazzo, MD

mpalazzo@kleinertkutz.com

Principal Investigator:

Michelle Palazzo, MD

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Michelle Palazzo, MD

mpalazzo@kleinertkutz.com

Principal Investigator:

Michelle Palazzo, MD

More Information

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Last update posted

Dec 9, 2020

Last verified

Dec, 2020

Keywords

  • ICNB
  • pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine M. Kleinert Institute for Hand and Microsurgery on 2020-12-09.