Breast Cancer
Conditions
Keywords
Breast Cancer, Reconstructive Surgery, Paravertebral Block, Anesthesia, Propofol, Fentanyl, Ropivacaine, Midazolam
Brief 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.
Detailed 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.
Interventions
PROCEDUREParavertebral Block
Paravertebral block given as a bolus injection into the paravertebral space.
DRUGPropofol
2-2.5 mg/kg IV over 1-4 hours during surgery.
DRUGFentanyl
50-250 mcg IV over 1-4 hours during surgery.
DRUGRopivacaine
Ropivacaine given by injection into the paravertebral space along the spinal canal.
DRUGMidazolam
0.08 mg/kg IV over 1-4 hours during the surgery.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With No Pain Immediately After Surgery | Starting immediately after surgery, every 2 hours till the 6th hour following 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). |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: September 10, 2007 to February 28, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment details
Of the 89 participants enrolled, one participant was excluded prior to group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Paravertebral Block + General Anesthesia Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal. | 44 |
| Group 2: General Anesthesia Alone General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery. | 44 |
| Total | 88 |
Baseline characteristics
| Characteristic | Group 1: Paravertebral Block + General Anesthesia | Group 2: General Anesthesia Alone | Total |
|---|---|---|---|
| Age, Continuous | 49 years | 51 years | 51 years |
| Region of Enrollment United States | 44 participants | 44 participants | 88 participants |
| Sex: Female, Male Female | 44 Participants | 44 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
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).
Time frame: Starting immediately after surgery, every 2 hours till the 6th hour following surgery
Population: Analysis was not possible from data collected due to reporting inconsistencies.