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Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02161705
Recruitment Status : Terminated (Poor accrual due to change in standard of care procedure.)
First Posted : June 12, 2014
Results First Posted : February 27, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
Plastic Surgery Educational Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Quality of Life Drug: Ropivacaine Drug: Saline Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pre-operative Paravertebral Blocks to Decrease Post-operative Pain Following Mastectomy With Immediate Tissue Expander Reconstruction
Actual Study Start Date : July 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : February 2019


Arm Intervention/treatment
Experimental: Ropivacaine Group
Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).
Drug: Ropivacaine
0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block
Other Name: Naropin

Placebo Comparator: Saline Group
Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.
Drug: Saline
Up to 0.8 mL/kg of normal saline administered
Other Name: Normal Saline




Primary Outcome Measures :
  1. Postoperative Static Pain Score [ Time Frame: Day of Surgery through Day 7 ]

    To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

    Post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed the Day of surgery through post-operative Day 7. A clinic visit occurs on Day 7 where additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires).

    Static pain refers to pain when the patient is at rest. Patients report pain on a scale of 0-10 were in 0 represents no pain and 10 the most severe pain they have experienced.



Secondary Outcome Measures :
  1. Quality of Life Scores as Assessed by the BREAST-Q Score [ Time Frame: Postoperative Day-30, Day-90 , 2-years, and 4-years (±14 days) after surgery. ]

    To determine if long-term changes in Quality of Life scores [BREAST-Q scores] differ between women undergoing mastectomy followed by immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

    The BREAST-Q score questionnaire items in each scale are arranged in a clinically relevant hierarchy (e.g., Satisfaction with Breasts scale ranges from "How satisfied are you with how you look in a mirror clothed?" to "How satisfied are you with how you look in the mirror unclothed?"). Scores will range from 0-100. Lower scores indicate lower quality of life and vice versa.

    This data will be collected via validated questionnaires through patient interviews at 1-month, 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/heal




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161705


Locations
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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Plastic Surgery Educational Foundation
Investigators
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Principal Investigator: Gedge D Rosson, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] September 29, 2015

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02161705    
Other Study ID Numbers: NA_00075957
311945 ( Other Grant/Funding Number: Plastic Surgery Education Foundation )
First Posted: June 12, 2014    Key Record Dates
Results First Posted: February 27, 2020
Last Update Posted: April 16, 2020
Last Verified: April 2020
Keywords provided by Johns Hopkins University:
Immediate breast reconstruction
pain control
post mastectomy pain control
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Nausea
Signs and Symptoms, Digestive
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents