Paravertebral Versus Pectoralis Block for Post Mastectomy Pain
TerminatedNot applicableNCT03656679
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Comparison of the Paravertebral Block Versus Pectoralis Block in Controlling Bilateral Post-mastectomy Pain in Setting of Tissue Expander Placement
- Conditions
- Pain, Postoperative
- Post-Mastectomy Chronic Pain Syndrome
- Opioid Use
- Interventions
- Procedure: Pectoralis Blockade (PECs)
- Procedure: Paravertebral Blockade
- Sponsor
- University of Wisconsin, Madison
- Start date
- 2018-10-18
- Primary completion
- 2020-02-28
- Sex
- Female
- Age range
- from 18 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03656679