Paravertebral Versus Pectoralis Block for Post Mastectomy Pain

NCT03656679 | Terminated DMC

• 6 other identifiers: 2018-0579NCI-2018-01743UW17141A530900SMPH/ANESTHESIOLOGY/ANESTHESIOProtocol Version 9/12/2019
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Post-mastectomy pain affects more than half of patients undergoing the procedure and can last for years. It has been well established that development of chronic pain is related to experienced pain in the perioperative period. This study therefore aims to assess if both acute and chronic post-operative mastectomy pain can be better managed by a novel regional anesthesia nerve block known as the pectoralis block (PECs). The PECs block is easier for patients to position for placement, has less risk of harm to nearby structures, and less risk for systemic uptake of local anesthetic in comparison to the paravertebral block. The PECs block has a strong safety profile. Standard of care at University of Wisconsin (UW) hospital is to utilize regional anesthesia for post op pain management. While PVB is performed on a regular basis at UW per surgeon request, Surgeon can request for PECS block in patients where a PVB was contraindicated (ie. coagulation issues). PECS is in fact the standard of care at other hospitals. This study will assess outcomes in the post anesthetic care unit (PACU), post-operative day 1, 7 and 30.

Conditions

Pain, Postoperative; Post-Mastectomy Chronic Pain Syndrome; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Total Opioid Consumption

  Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.

  24 hours

Secondary Outcomes (9)

• time to perform the block

  4 hours

• Pain score

  30 days

• Location of most severe pain

  30 days

• Presence or absence of axillary pain

  30 days

• Presence and severity of muscle spasm

  30 days

Study Arms (2)

Pectoralis Blockade(PECs)

ACTIVE COMPARATOR

Participants undergo pectoralis nerve block (PEC II) will received anesthesia between the pectoralis major and minor in the chest while lying flat.

Procedure: Pectoralis Blockade (PECs)

Paravertebral Blockade (PVB)

ACTIVE COMPARATOR

Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright.

Procedure: Paravertebral Blockade

Interventions

Pectoralis Blockade (PECs) PROCEDURE

Ten milliliters of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited between the pectoralis major and minor (PECs I) and 20 cc of 0.25% bupivacaine with 2.5mcg/ml epinephrine deposited between the pectoralis minor and serratus anterior muscle.

Pectoralis Blockade(PECs)

Paravertebral Blockade PROCEDURE

10cc of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited at two levels (T3 and T5) per side while in the sitting position.

Paravertebral Blockade (PVB)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The clinical decision has been made that the patient will have a bilateral mastectomy with tissue expander placement
• The participant is ≥ 18 years and ≤ 80 years
• Weight ≥ 60 kg and ≤ 90 kg
• The participant's primary anesthesia care team has planned for general anesthesia
• The participant agrees to receive a regional block
• American Society of Anesthesiologists class 1-3

You may not qualify if:

• years of age or \>80 years of age
• \< 60 kg or \> 90 kg
• Non-English speaking
• Known or believed to be pregnant
• Participant is a prisoner
• Participant has impaired decision-making capacity per discretion of the Investigator
• Standard contraindications to regional blocks (coagulopathy including abnormal INR after discontinuation of warfarin, baseline INR (international normalized ratio) \>1.5, platelets \<100,000, elevated PTT (prothrombin time), failure to discontinue anticoagulant medication, or infection at site)
• Significant renal, cardiac or hepatic disease per discretion of the investigator
• A clinical decision made that indicates need for a partial or complete axillary node dissection
• American Society of Anesthesiologists class 4-5
• Known hypersensitivity and/or allergies to local anesthetics
• Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months)
• Participant refusal

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Elizabeth Wilson, MD

  Anesthesiology Department, University of Wisonsin Hospital and Clinics, Madison, Wisconsin, United States,53792.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be provided with de-identified data for analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: September 4, 2018
• Study Start: October 18, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)