Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

NCT03152929 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 2016-306
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.

Conditions

Breast Cancer

Keywords

Surgery; Breast; Pectoral Nerve Block; Paravertebral Block; Analgesia; Mastectomy

Outcome Measures

Primary Outcomes (3)

• Intraoperative Narcotic Use

  Participants for whom Narcotics were used for pain during surgery

  intraoperatively, average of about 1 hour

• Post Anesthesia Care Unit (PACU) Narcotic Use

  Participants for whom Narcotics were used in PACU

  in PACU, generally 1-3 hours

• Postoperative Narcotic Use

  Participants for whom Narcotics were used postoperatively

  First 24 hours post-PACU (or until discharge)

Secondary Outcomes (6)

• Pain Control Measured by Length of Operation

  intraoperative

• Pain Control Measured by Estimated Blood Loss

  intraoperative

• Participants With Postoperative Nausea

  2 weeks postoperative

• Pain Control Measured by Pain Scale

  2 weeks postoperative

• Pain Control Measured by the Use of Pain Pills Postoperatively

  2 weeks postoperative

Study Arms (2)

Paravertebral Block

ACTIVE COMPARATOR

The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Drug: Paravertebral Block

Pectoral Nerve Block

ACTIVE COMPARATOR

The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Drug: Pectoral Nerve Block

Interventions

Paravertebral Block DRUG

20-30 mL 0.5% Ropivacaine

Also known as: PVB

Paravertebral Block

Pectoral Nerve Block DRUG

20-30 mL 0.5% Ropivacaine

Also known as: PEC

Pectoral Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients ≥ 18 years of age
• Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
• Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
• Patient agrees to participate in the study and signs informed consent

You may not qualify if:

• Neoadjuvant radiation therapy
• Stage IV cancer
• Previous breast surgery (excluding percutaneous biopsies of all types)
• History of either PVB or PEC procedures
• Planned general anesthesia use during surgery
• Allergies to ropivacaine, midazolam, fentanyl, or propofol
• Pregnant women
• Prisoners
• Adults unable to consent
• Non-English-speaking patients

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Esther L Peariso

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated early due to clinical practice outpacing the science of the trial. At the time of stopping enrollment, pectoral nerve blocks were being used standardly. Therefore, we could not ethically continue to randomize patients to both arms.

Results Point of Contact

• Title: Marianne Melnik
• Organization: Spectrum Health

marianne.melnik@corewellhealth.org

616-486-6333

Study Officials

• Marianne Melink, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block).

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: May 15, 2017
• Study Start: March 9, 2017
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: June 6, 2023
• Results First Posted: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)