Paravertebral Versus Pectoralis Block for Post Mastectomy Pain

Stopped early · Not applicable

Conditions studied: Pain, Postoperative, Post-Mastectomy Chronic Pain Syndrome, Opioid Use

In brief

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.

Key facts

Study ID

NCT03656679

Run by

University of Wisconsin, Madison

People needed

18

Starts

2018-10-18

Expected to finish

2020-02-28

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: accepted.

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…

• 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

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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