Phase 3
Completed N=88
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Source: ClinicalTrials.gov NCT00542542 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Proportion of Participants With No Pain Immediately After Surgery
Summary
Primary Objective:
To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia.
Secondary Objectives:
1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.
2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.
3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With No Pain Immediately After Surgery |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients that consent to participate
- Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone
- Patients that are female
- Patients that are over the age of 18
- Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.
Exclusion Criteria
- Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)
- Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's
- Patients with BMI 40
- Patients that are pregnant
- Patients with chronic pain syndromes.
- Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication
Data sourced from ClinicalTrials.gov (NCT00542542). 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. Informational only — not medical advice.