Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate TE Reconstruction
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/30/2019 |
| Start Date: | July 2014 |
| End Date: | December 2020 |
| Contact: | Ricardo J Bello, MD, MPH |
| Email: | rbello@jhmi.edu |
| Phone: | 410-955-7566 |
Pre-operative Paravertebral Blocks to Decrease Post-operative Pain Following Mastectomy With Immediate Tissue Expander Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women
undergoing bilateral mastectomy followed by bilateral immediate tissue expander
reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)
pre-operatively placed paravertebral blocks.
Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of
surgery while the patient is still hospitalized (post-operative day 0). This will be
patient-provided data. Unblinded data analysis will compare scores between treatment and
control groups.
Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,
and sleep interference differ between women undergoing bilateral mastectomy followed by
bilateral immediate tissue expander reconstruction randomized either to ropivacaine-
(treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.
Pain score, opioids use, nausea, and sleep interference data will be collected via patient
self-report. When possible (i.e., while hospitalized) objective data on opioids and other
pain medication administered to the patient will be used.
Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36
Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and
Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral
immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or
saline- (placebo) pre-operatively placed paravertebral blocks.
This data will be collected via validated questionnaires through patient interviews at
3-months, 2-years, and 4-years (±14 days) after surgery.
Once enrolled in the study, participants will be encouraged to remain in the study for the 4
years following surgery in order to get final pain scores and quality-of-life/health outcome
survey information. Participants who cannot be contacted after several phone attempts and the
sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year
outcome assessments will be considered lost to follow-up.
undergoing bilateral mastectomy followed by bilateral immediate tissue expander
reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)
pre-operatively placed paravertebral blocks.
Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of
surgery while the patient is still hospitalized (post-operative day 0). This will be
patient-provided data. Unblinded data analysis will compare scores between treatment and
control groups.
Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,
and sleep interference differ between women undergoing bilateral mastectomy followed by
bilateral immediate tissue expander reconstruction randomized either to ropivacaine-
(treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.
Pain score, opioids use, nausea, and sleep interference data will be collected via patient
self-report. When possible (i.e., while hospitalized) objective data on opioids and other
pain medication administered to the patient will be used.
Tertiary Objectives To determine if long-term changes in Quality of Life scores [the RAND-36
Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and
Breast-Q scores] differ between women undergoing bilateral mastectomy followed by bilateral
immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or
saline- (placebo) pre-operatively placed paravertebral blocks.
This data will be collected via validated questionnaires through patient interviews at
3-months, 2-years, and 4-years (±14 days) after surgery.
Once enrolled in the study, participants will be encouraged to remain in the study for the 4
years following surgery in order to get final pain scores and quality-of-life/health outcome
survey information. Participants who cannot be contacted after several phone attempts and the
sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year
outcome assessments will be considered lost to follow-up.
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and
pain medication/narcotic use between patients randomized to treatment (ropivacaine) or
placebo (saline) delivered via paravertebral block to the mastectomy site. Candidates will
have chosen to have a mastectomy on one side immediately followed with tissue expander
placement breast reconstruction.
Patients will be randomized 1:1 to ropivacaine- (treatment) or saline-(placebo) paravertebral
blocks in a double-blinded design. Patient-specific surgical details will be recorded
intraoperatively. Following the surgery, post-operative pain, pain medication/opioid use, and
the occurrence of adverse events (AEs)/serious adverse events (SAEs) will be assessed on Days
1, 2, and 3. A clinic visit occurs on Day 7 when additional data are collected (updated
medical history, pain medication/opioid use, AEs/SAEs, and study questionnaires. Using two
pain scales, the Patient Pain Assessment Questionnaire (Appendix A) and Subjective Pain
Survey (Appendix B), the post-operative pain will be compared between treatment and control
groups. Differences in opioids use between groups at different time points will also be
assessed as a more objective measure of post-operative pain.
Long-term quality-of-life/health outcomes assessments will be done on post-operative Day 90
(±14 days), Year 2 (±14 days), and Year 4 (±14 days). The Year 2 and Year 4 follow-ups are
included as tertiary endpoints to capture differences in chronic pain, and patients will be
asked to complete the same questionnaires as at the Day 90 follow up.
The investigators hypothesize that post-operative static pain scores will be lower in
ropivacaine patients vs. placebo patients in women undergoing mastectomy and immediate
reconstruction with placement of tissue expanders. We believe that post-operative moving pain
scores, opioids use, nausea, and sleep interference will be likewise improved. We further
hypothesize that this decreased post-operative pain may lead to improvements in long-term
health outcomes as measured by validated questionnaires. In the presence of clear need and
lack of published studies regarding this precise patient population, it is important to
determine if paravertebral blocks do reduce post-operative pain, and improve opioids use,
nausea, sleep interference, and length of hospital stay in patients undergoing immediate
tissue expander breast reconstruction.
pain medication/narcotic use between patients randomized to treatment (ropivacaine) or
placebo (saline) delivered via paravertebral block to the mastectomy site. Candidates will
have chosen to have a mastectomy on one side immediately followed with tissue expander
placement breast reconstruction.
Patients will be randomized 1:1 to ropivacaine- (treatment) or saline-(placebo) paravertebral
blocks in a double-blinded design. Patient-specific surgical details will be recorded
intraoperatively. Following the surgery, post-operative pain, pain medication/opioid use, and
the occurrence of adverse events (AEs)/serious adverse events (SAEs) will be assessed on Days
1, 2, and 3. A clinic visit occurs on Day 7 when additional data are collected (updated
medical history, pain medication/opioid use, AEs/SAEs, and study questionnaires. Using two
pain scales, the Patient Pain Assessment Questionnaire (Appendix A) and Subjective Pain
Survey (Appendix B), the post-operative pain will be compared between treatment and control
groups. Differences in opioids use between groups at different time points will also be
assessed as a more objective measure of post-operative pain.
Long-term quality-of-life/health outcomes assessments will be done on post-operative Day 90
(±14 days), Year 2 (±14 days), and Year 4 (±14 days). The Year 2 and Year 4 follow-ups are
included as tertiary endpoints to capture differences in chronic pain, and patients will be
asked to complete the same questionnaires as at the Day 90 follow up.
The investigators hypothesize that post-operative static pain scores will be lower in
ropivacaine patients vs. placebo patients in women undergoing mastectomy and immediate
reconstruction with placement of tissue expanders. We believe that post-operative moving pain
scores, opioids use, nausea, and sleep interference will be likewise improved. We further
hypothesize that this decreased post-operative pain may lead to improvements in long-term
health outcomes as measured by validated questionnaires. In the presence of clear need and
lack of published studies regarding this precise patient population, it is important to
determine if paravertebral blocks do reduce post-operative pain, and improve opioids use,
nausea, sleep interference, and length of hospital stay in patients undergoing immediate
tissue expander breast reconstruction.
Inclusion Criteria:
- Be Female aged 18-100 years.
- Choose mastectomy followed by bilateral immediate tissue expander breast
reconstruction.
- Have no inflammatory breast cancers.
- Be aware of the nature of her malignancy.
- Understand the study purpose, requirements, and risks.
- Be able and willing to give informed consent.
Exclusion Criteria:
- Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible).
- Liver dysfunction and/ or cirrhosis.
- Renal insufficiency, with creatinine greater than 1.5 mg/mL.
- Patients weighing less than 50 Kg.
- Concurrent use of the SSRI antidepressant fluvoxamine (Luvox).
We found this trial at
1
site
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Phone: 410-955-7566
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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