Evaluating the Effectiveness of Bilateral ESPB in Addition to Standard Analgesia at Reducing Opioid Consumption

NCT03954249 | Completed DMC

• 1 other identifier: 2019-10183
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Study the benefits of a Erector Spinae nerve block for pain control and decrease narcotics usage after mammoplasty in an ambulatory setting

Conditions

Anesthesia; Block

Keywords

erector spinae plane block; multimodal anesthesia

Outcome Measures

Primary Outcomes (1)

• Use of narcotics in first 24 hours

  The cumulative dose of oral morphine equivalence used in the 24 hours post surgery in morphine equivalents.

  24 hours

Secondary Outcomes (4)

• Postoperative nausea and vomiting

  Up to 1 day after surgery

• Length of stay in PACU

  Up to 5 Hours in PACU

• Assessment of postoperative pain

  Up to 5 Hours in PACU

• Patient Satisfaction

  Up to 1 day after surgery

Study Arms (2)

Erector Spinae nerve block group

EXPERIMENTAL

Receive multimodal analgesia and in addition erector spinae plane block

Procedure: Erecto Spinae nerve block

Multimodal Analgesia group

ACTIVE COMPARATOR

Receive standard multimodal analgesia

Procedure: Multimodal Analgesia

Interventions

Erecto Spinae nerve block PROCEDURE

The ESPB is a myofascial block alternative to the paravertebral block. It is performed by injecting local anesthetic in the plane between the erector spinae muscle and the spinal transverse process. The ESPB is thought to be safer than the paravertebral block because the transverse process acts as a barrier to the pleura. It has been postulated that local anesthetic spread reaches the paravertebral space and in fact, cadaveric studies have shown dye spreading to involve the ventral and dorsal rami of spinal nerves.

Erector Spinae nerve block group

Multimodal Analgesia PROCEDURE

Patients in the control group will receive standard 100mg pregabalin PO, midazolam 2mg IV, fentanyl 100mcg IV.

Multimodal Analgesia group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing reduction mammoplasty
• Age \>18 years
• ASA class I-III

You may not qualify if:

• Patient refusal
• Renal insufficiency (defined as CKD stage 3 or greater)
• Infection at the skin at the site of needle puncture
• Known allergies to any study drugs
• Coagulopathy
• Severe asthmatics
• BMI \>40
• ASA 4 and 5
• Pre-existing pain disorder
• Regular consumption of chronic pain medication
• Failed block
• Diagnosis of OSA

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Elilary Montilla Medrano, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: November 7, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)