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

Phase 3
Terminated
Conditions
Breast Cancer
Interventions
Drug: Paravertebral Block
Drug: Pectoral Nerve Block
Registration Number
NCT03152929
Lead Sponsor
Spectrum Health Hospitals
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.

Detailed Description

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).

The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
89
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Paravertebral BlockParavertebral BlockThe Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
Pectoral Nerve BlockPectoral Nerve BlockThe Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)
Primary Outcome Measures
NameTimeMethod
Postoperative Narcotic UseFirst 24 hours post-PACU (or until discharge)

Participants for whom Narcotics were used postoperatively

Intraoperative Narcotic Useintraoperatively, average of about 1 hour

Participants for whom Narcotics were used for pain during surgery

Post Anesthesia Care Unit (PACU) Narcotic Usein PACU, generally 1-3 hours

Participants for whom Narcotics were used in PACU

Secondary Outcome Measures
NameTimeMethod
Pain Control Measured by Pain Scale2 weeks postoperative

Pain measured on scale of one to ten, one being least amount of pain and ten the greatest.

Pain Control Measured by Length of Operationintraoperative

Measuring pain control by how long (in minutes) patient is in surgery

Pain Control Measured by Estimated Blood Lossintraoperative

Measuring blood loss (in ml) during surgery

Participants With Postoperative Nausea2 weeks postoperative

count of participants who reported nausea after surgery

Pain Control Measured by the Use of Pain Pills Postoperatively2 weeks postoperative

Participants who used narcotic pain pills postoperatively

Pain Control Measured by Calls to Physicians Office Relating to Pain2 weeks postoperative

Number of phone calls made to physician office regarding pain

Trial Locations

Locations (1)

Esther L Peariso

🇺🇸

Grand Rapids, Michigan, United States

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