Postoperative Nausea and Vomiting, Postoperative Pain, Quality of Life
Conditions
Keywords
Immediate breast reconstruction, pain control, post mastectomy pain control
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.
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.
Interventions
DRUGRopivacaine
0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block
DRUGSaline
Up to 0.8 mL/kg of normal saline administered
Sponsors
The Plastic Surgery Foundation
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Static Pain Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scores as Assessed by the BREAST-Q Score | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block | 9 |
| 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.
Saline: Up to 0.8 mL/kg of normal saline administered | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Total | Saline Group | Ropivacaine Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 8 Participants | 9 Participants |
| Age, Continuous | 53.5 Years | 54 Years | 50 Years |
| Moving Pain Score | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 7 Participants | 8 Participants |
| Region of Enrollment United States | 18 participants | 9 participants | 9 participants |
| Sex: Female, Male Female | 18 Participants | 9 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Static Pain Score | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Subjective Pain Score | 3.38 units on a scale | 3.69 units on a scale | 3.38 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Postoperative Static Pain Score
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.
Time frame: Day of Surgery through Day 7
Population: 1 Patient in the saline group was lost to follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Group | Postoperative Static Pain Score | 1.5 units on a scale |
| Saline Group | Postoperative Static Pain Score | 1 units on a scale |
Secondary
Quality of Life Scores as Assessed by the BREAST-Q Score
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
Time frame: Postoperative Day-30, Day-90 , 2-years, and 4-years (±14 days) after surgery.
Population: The minimum data needed to assess this outcome measure was not collected for any participant and thus could not be analyzed for any of the participants.