Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Anesthetics; Fentanyl; Midazolam; Propofol; Ropivacaine

Criteria

Inclusion Criteria:

1. Patients that consent to participate

2. Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone

3. Patients that are female

4. Patients that are over the age of 18

5. 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:

1. Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)

2. Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's

3. Patients with BMI<20 or >40

4. Patients that are pregnant

5. Patients with chronic pain syndromes.

6. Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication