Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
|ClinicalTrials.gov Identifier: NCT00542542|
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Paravertebral Block Drug: Propofol Drug: Fentanyl Drug: Ropivacaine Drug: Midazolam||Phase 3|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery|
|Study Start Date :||September 2007|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Active Comparator: Paravertebral Block + General Anesthesia
Group 1: Paravertebral Block + General Anesthesia (Ropivacaine)
Procedure: Paravertebral Block
Paravertebral block given as a bolus injection into the paravertebral space.Drug: Ropivacaine
Ropivacaine given by injection into the paravertebral space along the spinal canal.
Active Comparator: General Anesthesia Alone
Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
2-2.5 mg/kg IV over 1-4 hours during surgery.Drug: Fentanyl
50-250 mcg IV over 1-4 hours during surgery.Drug: Midazolam
0.08 mg/kg IV over 1-4 hours during the surgery.
- Proportion of Participants With No Pain Immediately After Surgery [ Time Frame: 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542542
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farzin Goravanchi, MD||M.D. Anderson Cancer Center|