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ICNBs for Post-op Pain in Breast Surgery

C

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase

Unknown
Phase 4

Conditions

Length of Stay
Pain, Postoperative

Treatments

Drug: Bupivacaine Hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT04606836
20.0781

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Prospective Cases
Experimental group
Description:
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).
Treatment:
Drug: Bupivacaine Hydrochloride
Retrospective Controls
No Intervention group
Description:
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.

Trial contacts and locations

5

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Central trial contact

Julianne Sutton, MPH

Data sourced from clinicaltrials.gov

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