Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

Breast Cancer Clinical Trial

Official title:

Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542542
• Other study ID #: 2006-0961
• Secondary ID: NCI-2012-01557
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2007
• Last updated: March 31, 2015
• Start date: September 2007
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Paravertebral Blocks and General Anesthesia The use of a paravertebral block involves injecting local anesthesia (a numbing medicine) into the patient's back to numb specific areas (the breast[s] for this study) for surgery.

General anesthesia is medicine that is used to put patients to sleep so that there is no feeling of pain.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. You will have an equal (50/50) chance of being assigned to either group.

Participants in one group will receive a paravertebral block (the local anesthetic ropivacaine) plus general anesthesia.

Participants in the other group will receive general anesthesia (propofol, desflurane, and fentanyl) without a paravertebral block.

Drug Administration:

If you are assigned to receive the paravertebral block plus general anesthesia, you will have a paravertebral block placed just before surgery begins. Ropivacaine will be given by injection into the paravertebral space along the spinal canal.

If you are assigned to receive general anesthesia without a paravertebral block, you will be given propofol, desflurane, and fentanyl by vein over 1-4 hours during surgery.

Participants in both groups will receive promethazine, famotidine, and dexamethasone at the start of surgery to help decrease or eliminate nausea and vomiting that may occur after surgery.

Follow-up:

After your surgery is complete, before you leave the hospital, you will have the following evaluations:

• You will be asked how you are feeling so that the study doctor can determine how much medication you may need for pain and nausea as well as how long your hospital stay may need to be. You may be given fentanyl and dilaudid for pain and ondansetron and promethazine for nausea.

• You will also be asked about your satisfaction with the anesthesia. You will be asked these questions within the first hour, between 1 and 3 hours, and between 3 and 6 hours after surgery. Once you are discharged from the hospital, study staff will contact you by phone or talk with you when you return for a visit (at 18 -22 hours and 1 week after surgery) to ask these questions. It will take about 3-5 minutes to ask these questions each time.

Length of Study:

Your participation in this study will be over after the 1 week follow-up telephone call.

This is an investigational study. Paravertebral blocks and general anesthesia are FDA approved and commercially available. Up to 89 patients will take part in this study. All will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Paravertebral Block
Paravertebral block given as a bolus injection into the paravertebral space.

Drug:
• Propofol
2-2.5 mg/kg IV over 1-4 hours during surgery.
• Fentanyl
50-250 mcg IV over 1-4 hours during surgery.
• Ropivacaine
Ropivacaine given by injection into the paravertebral space along the spinal canal.
• Midazolam
0.08 mg/kg IV over 1-4 hours during the surgery.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With No Pain Immediately After Surgery	Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).	Starting immediately after surgery, every 2 hours till the 6th hour following surgery	No

External Links

•   MD Anderson Cancer Center