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Phase 3 N=2,108 Randomized Prevention

Regional Anesthesia and Breast Cancer Recurrence

Breast Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00418457 ↗
Enrolled (actual)
2,108
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery — 111; 102 participants — p=0.84

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
General anesthesia and opioids (Drug); Regional analgesia and propofol (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
The Cleveland Clinic
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery		 111; 102 0.84
SECONDARY
Number of Participants That Experienced Post-Surgical Pain		 456; 442; 232; 239 0.70
SECONDARY
Number of Participants That Experienced Neuropathic Pain After Surgery		 89; 87; 57; 57 0.81
SECONDARY
SF-12 PCS Score		 49.7; 49.8; 52.3; 52.1 0.96
SECONDARY
SF-12 MCS Score		 48.1; 48.7; 48; 48.7 0.043 sig

Summary

In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.

Eligibility Criteria

Inclusion Criteria

  • Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)
  • Scheduled for unilateral or bilateral mastectomy with or without implant (isolated "lumpectomy" will not qualify)
  • Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least five nodes)
  • Written informed consent, including willingness to be randomized to morphine or regional analgesia

Exclusion Criteria

  • Previous surgery for breast cancer (except diagnostic biopsies)
  • Inflammatory breast cancer
  • Age 85 years old
  • Scheduled free flap reconstruction
  • ASA Physical Status ≥ 4
  • Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)
  • Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine
  • Other cancer not believed by the attending surgeon to be in long-term remission
  • Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00418457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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