Phase 3 N=88 Randomized Diagnostic

Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00542542 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Proportion of Participants With No Pain Immediately After Surgery

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Paravertebral Block (Procedure); Propofol (Drug); Fentanyl (Drug); Ropivacaine (Drug); Midazolam (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: M.D. Anderson Cancer Center
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.

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

View full record on ClinicalTrials.gov →

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.