An interventional study of Pectoralis Blockade (PECs) and Paravertebral Blockade in Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome and Opioid Use, sponsored by University of Wisconsin, Madison. Terminated at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
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)
Participants undergoing paravertebral nerve block (PVB) consisting of receiving anesthesia in the back while sitting upright.
Procedure: Paravertebral Blockade
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.
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.
Total Opioid Consumption
Primary outcome will be total opioid consumption in 24 hours for Paravertebral Nerve Block vs. Pectoralis Nerve Block.
Time frame: 24 hours
time to perform the block
To compare the following perioperative variables (pre/intraoperative): time to perform the block.
Time frame: 4 hours
Pain score
To compare the following perioperative variables: pain score at time of PACU, POD 1, 7 and 30
Time frame: 30 days
Location of most severe pain
To compare the following perioperative variables location of most severe pain at PACU, POD 1, 7 and 30
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
Total muscle relaxant consumption
To compare the following perioperative variables: total muscle relaxant consumption at PACU, POD 1, 7 and 30
Time frame: 30 days
Total antiemetic consumption
To compare the following perioperative variables: total antiemetic consumption at PACU and POD 1
Time frame: 48 hours
Time in PACU and hospital duration
To compare the following perioperative variables : time in PACU and hospital duration
Time frame: 48 hours
Opioid consumption at POD 7 and 30
To compare the following perioperative variables : Opioid consumption at POD 7 and 30
Time frame: 30 days
Plan to share: No
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University of Wisconsin, Madison