Breast CancerPhase 3NCT00542542
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
A Phase 3 study testing Paravertebral Block, Propofol and Fentanyl in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paravertebral Block, Propofol and Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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<20 or >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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery
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.
Read more
Secondary Objectives:
- 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Paravertebral Block, Propofol, Fentanyl, Ropivacaine, Midazolam
- Keywords
- Breast Cancer, Reconstructive Surgery, Paravertebral Block, Anesthesia, Propofol, Fentanyl, Ropivacaine, Midazolam
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral BlockProcedure or surgery
Paravertebral block given as a bolus injection into the paravertebral space.
PropofolDrug
2-2.5 mg/kg IV over 1-4 hours during surgery.
FentanylDrug
50-250 mcg IV over 1-4 hours during surgery.
RopivacaineDrug
Ropivacaine given by injection into the paravertebral space along the spinal canal.
MidazolamDrug
0.08 mg/kg IV over 1-4 hours during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block + General Anesthesia | Active comparator | Group 1: Paravertebral Block + General Anesthesia (Ropivacaine) Receives: Procedure: Paravertebral Block; Drug: Ropivacaine |
| General Anesthesia Alone | Active comparator | Group 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl) Receives: Drug: Propofol; Drug: Fentanyl; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Starting immediately after surgery, every 2 hours till the 6th hour following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farzin Goravanchi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542542
- Sponsor's protocol ID
- 2006-0961
- Other IDs
- NCI-2012-01557
- Status last verified
- Mar 2015
- First submitted
- 10 Oct 2007
- Last updated
- 13 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery
- ClinicalTrials.gov ID
- NCT00542542
- Acronym / sponsor ID
- 2006-0961
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Reconstructive Surgery, Paravertebral Block, Anesthesia, Propofol, Fentanyl, Ropivacaine, Midazolam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Posted 13 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block + General Anesthesia | Active comparator | Procedure: Paravertebral Block, Drug: RopivacaineGroup 1: Paravertebral Block + General Anesthesia (Ropivacaine) |
| General Anesthesia Alone | Active comparator | Drug: Propofol, Drug: Fentanyl, Drug: MidazolamGroup 2: General Anesthesia Alone (Propofol, Midazolam, Fentanyl) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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<20 or >40
- Patients that are pregnant
- Patients with chronic pain syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral BlockParavertebral block given as a bolus injection into the paravertebral space. | Procedure or surgery | Paravertebral Block + General Anesthesia |
| Propofol2-2.5 mg/kg IV over 1-4 hours during surgery. | Drug | General Anesthesia Alone |
| Fentanyl50-250 mcg IV over 1-4 hours during surgery. | Drug | General Anesthesia Alone |
| RopivacaineRopivacaine given by injection into the paravertebral space along the spinal canal. | Drug | Paravertebral Block + General Anesthesia |
| Midazolam0.08 mg/kg IV over 1-4 hours during the surgery. | Drug | General Anesthesia Alone |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzin Goravanchi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paravertebral Block, Propofol and Fentanyl in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With No Pain Immediately After Surgery (time frame: Starting immediately after surgery, every 2 hours till the 6th hour following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.