Pain, Postoperative, Postoperative Nausea and Vomiting
Conditions
Keywords
Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge
Brief summary
The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower numbers of hospital readmissions than the use of tumescent solution containing only dilute epinephrine.
Detailed description
Postoperative pain is often undermanaged in surgical patients. In the outpatient surgery population, such as breast reduction surgery, postoperative pain can lead to increased narcotic use, increased nausea, surgical complications and unplanned hospital admission, in addition to patient discomfort or dissatisfaction. Tumescence is a method of infiltrating tissues, such as the breast, with solutions of very dilute lidocaine and/or very dilute epinephrine in order to provide diffuse local anesthesia, hemostasis, and tissue manipulation. Both types of solution are considered standard care and both at the University of Wisconsin, Madison. There are two main aims to this study. Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. Aim 2 of our study is to determine the effect of dilute lidocaine in tumescent solution on secondary post-operative outcomes following breast reduction surgery. The secondary outcomes that will be measured in this study include average time (minutes) spent in the postanesthesia care unit (PACU), average time (minutes) spent in Phase 2, total time (minutes) between the end of case and discharge home, occurrence of unplanned hospital admission, number of episodes of post-operative nausea (subjective feeling vs. emesis) and amount of anti-emetic medication used in pacu, phase 2 and the first 24 hours post-op (mg). The investigators hypothesize that tumescence with lidocaine and epinephrine will have improved post-operative pain control leading to less narcotic use during the first twenty four hours postoperatively. (Aim 1). The investigators also believe that tumescence with lidocaine and epinephrine will lead to less time spent in PACU, less time spent in Phase2, less time between the end of the case and discharge home, less occurrence of unplanned hospital admissions, less episodes of post-operative nausea and less amount of antiemetic medication used in PACU, phase 2 and the first 24 hours post-op (Aim 2). The investigators propose that such differences could play a significant role in surgical outcomes and patient satisfaction in outpatient plastic surgery.
Interventions
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
DRUGTumescent Solution with dilute epinephrine
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all patients presenting for breast reduction surgery at the University of Wisconsin Hospital and Clinics and the University of Wisconsin Transformations Surgery Center and who do not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | Up to 24 hours following surgery | Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record. |
| Amount of Post-Operative Narcotic Medication Administered | Up to 24 hours following surgery | Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) | Up to 24 hours following surgery | The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. |
| Post Operative Nausea and Vomiting | Up to 24 hours following surgery | The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions. |
| Unplanned Hospital Readmission | Up to 1 week following surgery | The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery. |
| Time to Discharge | Up to 24 hours following surgery | The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge. |
| Anti-emetic / Intraoperative Medication Administered (mg) | Up to 24 hours following surgery | The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions. |
Countries
United States
Participant flow
Recruitment details
female candidates presenting for bilateral breast reduction at the University of Wisconsin ambulatory surgery center performed by a single surgeon (Dr. Rao)
Participants by arm
| Arm | Count |
|---|---|
| Tumescent Solution With Dilute Epinephrine Participants in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction.
Tumescent Solution with dilute epinephrine: Tumescent Solution containing dilute epinephrine (1:1,000,000) only | 20 |
| Tumescent Solution With Dilute Lidocaine and Epinephrine Participants in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000).
Tumescent solution with dilute lidocaine and epinephrine: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000) | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Tumescent Solution With Dilute Epinephrine | Total | Tumescent Solution With Dilute Lidocaine and Epinephrine |
|---|---|---|---|
| Active Smoker | 5 percentage of participants | 10 percentage of participants | 15 percentage of participants |
| Age, Continuous | 42 years | 41.5 years | 41 years |
| History of post-op nausea | 20 percentage of participants | 15 percentage of participants | 10 percentage of participants |
| History of previous breast surgery | 0 percentage of participants | 12.5 percentage of participants | 25 percentage of participants |
| Mean Body Mass Index (BMI) | 31 kg/m^2 | 32 kg/m^2 | 33 kg/m^2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 8 / 20 | 10 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Amount of Post-Operative Narcotic Medication Administered
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Amount of Post-Operative Narcotic Medication Administered | PACU IV hydromorphone | 0.89 mg |
| Tumescent Solution With Dilute Epinephrine | Amount of Post-Operative Narcotic Medication Administered | First 24 hr Post-op oxycodone | 32.19 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Amount of Post-Operative Narcotic Medication Administered | PACU IV hydromorphone | 0.55 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Amount of Post-Operative Narcotic Medication Administered | First 24 hr Post-op oxycodone | 29.47 mg |
Comparison: PACU IV hydromorphone p-value between armsp-value: 0.1ANOVA
Comparison: First 24 hr Post-op oxycodone p-value between armsp-value: 0.71ANOVA
Primary
Post-operative Pain
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Post-operative Pain | End of PACU Mean Pain Level | 5.47 score on a scale |
| Tumescent Solution With Dilute Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Current Pain | 4.00 score on a scale |
| Tumescent Solution With Dilute Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Worst Pain | 6.44 score on a scale |
| Tumescent Solution With Dilute Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Least Pain | 2.00 score on a scale |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Least Pain | 2.53 score on a scale |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post-operative Pain | End of PACU Mean Pain Level | 4.47 score on a scale |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Worst Pain | 6.68 score on a scale |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post-operative Pain | First 24 hrs Post-op Mean Current Pain | 4.28 score on a scale |
Comparison: End of PACU Mean Pain Level p-value between armsp-value: 0.24ANOVA
Comparison: First 24 hrs Post-op Mean Current Pain p-value between armsp-value: 0.76ANOVA
Comparison: First 24 hrs Post-op Mean Worst Pain p-value between armsp-value: 0.78ANOVA
Comparison: First 24 hrs Post-op Mean Least Pain p-value between armsp-value: 0.41ANOVA
Secondary
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) | 131.30 micrograms |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms) | 120.00 micrograms |
Secondary
Anti-emetic / Intraoperative Medication Administered (mg)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative midazolam | 2.00 mg |
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative dexamethasone | 6.40 mg |
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative ketorolac | 11.25 mg |
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative ondansetron | 3.60 mg |
| Tumescent Solution With Dilute Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative hydromorphone | 0.98 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative ondansetron | 4.05 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative hydromorphone | 1.06 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative midazolam | 1.90 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative ketorolac | 16.50 mg |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Anti-emetic / Intraoperative Medication Administered (mg) | Mean Intraoperative dexamethasone | 6.00 mg |
Secondary
Post Operative Nausea and Vomiting
The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions.
Time frame: Up to 24 hours following surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Post Operative Nausea and Vomiting | Nausea | 8 episodes |
| Tumescent Solution With Dilute Epinephrine | Post Operative Nausea and Vomiting | Vomiting | 2 episodes |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post Operative Nausea and Vomiting | Nausea | 10 episodes |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Post Operative Nausea and Vomiting | Vomiting | 4 episodes |
Secondary
Time to Discharge
The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge.
Time frame: Up to 24 hours following surgery
Population: Time to discharge data not was reported for all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Time to Discharge | 158 minutes | Standard Deviation 40.5 |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Time to Discharge | 153 minutes | Standard Deviation 29.9 |
Secondary
Unplanned Hospital Readmission
The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery.
Time frame: Up to 1 week following surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tumescent Solution With Dilute Epinephrine | Unplanned Hospital Readmission | 0 Participants |
| Tumescent Solution With Dilute Lidocaine and Epinephrine | Unplanned Hospital Readmission | 0 Participants |