Paravertebral Versus Pectoralis Block for Post Mastectomy Pain



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:11/7/2018
Start Date:October 18, 2018
End Date:December 1, 2021
Contact:Elizabeth Wilson, MD
Email:eahickma@wisc.edu
Phone:6082655980

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

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.

Inclusion Criteria:

- The clinical decision has been made that the patient will have a bilateral mastectomy
with tissue expander placement

- The patient is ≥ 18 years and ≤ 80 years

- Weight ≥ 60 kg and ≤ 90 kg;

- The patient's primary anesthesia care team has planned for general anesthesia;

- The patient 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;

- Patient is a prisoner;

- Patient 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)

- Patient refusal.
We found this trial at
1
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-265-5980
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