Paravertebral Versus Pectoralis Block for Post Mastectomy Pain

Pain, Postoperative Clinical Trial

Official title:

A Comparison of the Paravertebral Block Versus Pectoralis Block in Controlling Bilateral Post-mastectomy Pain in Setting of Tissue Expander Placement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03656679
• Other study ID #: 2018-0579
• Secondary ID: NCI-2018-01743UW
• Status: Terminated
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Post-mastectomy pain occurs in up to 55% of patients and can last for months. The development of chronic pain is related to experienced perioperative pain. The development of chronic pain is related to experienced perioperative pain. There is great potential to enhance the quality of life for breast surgery patients if the hospital can improve our perioperative pain prevention techniques. New to the spectrum of multimodal analgesia is the pectoralis block (PECs), which provides anesthesia to the anterior and anterior lateral chest wall as well to the axilla. This study is about aims to compare the pectoralis block to paravertebral block with benefits of ease placement, less risk for harm to nearby structures including pneumothorax, spinal cord trauma, sympathetic block and hypotension. Literature reveals that the pectoralis block has provided improved pain scores as well as decreases post-operative nausea and vomiting, longer block duration, and subsequent pain relief in patient. Despite these promising preliminary studies, there remains a paucity on the effectiveness of the PECs Block, particularly regarding long term outcomes for patients. Furthermore, there is no literature to date which has evaluated the best regional anesthetic technique for patients who receive breast tissue expanders, which can cause a significant amount of muscle pain and spasm due to the intended muscle disruption during surgical placement. The primary outcomes of this study is to compare total opioid consumption during the post-surgical period limited to 24 hrs beginning at PACU admission between patients who receive bilateral pectoralis plane versus bilateral paravertebral blocks and subsequently undergo bilateral mastectomy with tissue expanders. The secondary outcomes includes post-operative pain scores on PACU arrival and discharge, post-operative days (POD) 1, 7, and 30, presence/absence of axillary pain, muscle relaxant consumption, presence of severity of muscle spasm, total antiemetic consumption 24-hrs beginning at PACU admission, presence of chronic opioid use (Defined as consumption at 30 days), time to perform block, and PACU duration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 18 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Pectoralis Blockade (PECs)
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.
• Paravertebral Blockade
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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption	Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.	24 hours
Secondary	time to perform the block	To compare the following perioperative variables (pre/intraoperative): time to perform the block.	4 hours
Secondary	Pain score	To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30	30 days
Secondary	Location of most severe pain	To compare the following perioperative variables location of most severe pain at PACU, POD 1, 7 and 30	30 days
Secondary	Presence or absence of axillary pain	To compare the following perioperative variables: presence or absence of axillary pain at PACU, POD 1, 7 and 30	30 days
Secondary	Presence and severity of muscle spasm	To compare the following perioperative variables : presence and severity of muscle spasm at PACU, POD 1, 7 and 30	30 days
Secondary	Total muscle relaxant consumption	To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30	30 days
Secondary	Total antiemetic consumption	To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1	48 hours
Secondary	Time in PACU and hospital duration	To compare the following perioperative variables : time in PACU and hospital duration	48 hours
Secondary	Opioid consumption at POD 7 and 30	To compare the following perioperative variables : Opioid consumption at POD 7 and 30	30 days