Mammaplasty, Pain, Postoperative
Conditions
Brief summary
The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
Detailed description
The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty. Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm. The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.
Interventions
DRUGDexamethasone 4mg
The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
DRUGSaline
The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Sponsors
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The surgeon (investigator), patient, and anesthesiologists were not aware of which arm each participant was assigned to. Furthermore, each injected analgesic was premixed and uniformly labeled to maintain blinding.
Intervention model description
Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female * Age 18-80 * Bilateral reduction mammaplasty * American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 * Must choose to receive preoperative nerve block as part of pain management strategy
Exclusion criteria
* Allergy to dexamethasone or bupivacaine * History of postoperative nausea and vomiting following anesthesia * History of chronic pain conditions * History of narcotic abuse or dependency * History of chronic renal disease * History of chronic liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Visual Analog Scale (VAS) Pain Scores | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 4-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 8-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 12-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 16-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 20-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| 24-hour Visual Analog Scale (VAS) Pain Scores | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) |
| Narcotic Consumption | Up to 24 hours postoperatively | Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4-hour Oxygen Saturation | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| 8-hour Oxygen Saturation | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| 12-hour Oxygen Saturation | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| 16-hour Oxygen Saturation | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| Initial Blood Pressure | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 24-hour Oxygen Saturation | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| Number of Patients Administered Anti-emetics at 4-hour Intervals | Initial, 4, 8, 12, 16, 20, and 24 hours | Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals |
| Short-form 36-item (Sf-36) Quality of Life Questionnaire | 1 week to 2 months postoperatively | Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category. |
| Rate of Wound Complications | 1 week to 2 months postoperatively | Assessment of wound complications during any postoperative clinic visit |
| 20-hour Oxygen Saturation | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
| 4-hour Blood Pressure | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 8-hour Blood Pressure | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 12-hour Blood Pressure | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 16-hour Blood Pressure | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 20-hour Blood Pressure | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| 24-hour Blood Pressure | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) | Systolic blood pressure |
| Initial Oxygen Saturation | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) | SpO2 as measured by pulse oximetry |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | 26 |
| Experimental Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Hospitalization and Wound Follow-up | Protocol Violation | 0 | 5 |
| SF-36 Quality of Life Survey Completion | Lost to Follow-up | 12 | 6 |
Baseline characteristics
| Characteristic | Total | Experimental | Control |
|---|---|---|---|
| Abnormal Uterine Bleeding | 1 Participants | 1 Participants | 0 Participants |
| Age, Continuous | 40.57 years STANDARD_DEVIATION 14.29 | 42.48 years STANDARD_DEVIATION 15.17 | 38.73 years STANDARD_DEVIATION 13.44 |
| Anemia | 9 Participants | 5 Participants | 4 Participants |
| Anxiety | 9 Participants | 5 Participants | 4 Participants |
| Asthma | 11 Participants | 7 Participants | 4 Participants |
| Body Mass Index (BMI) | 33.37 kg/m^2 STANDARD_DEVIATION 12.07 | 34.12 kg/m^2 STANDARD_DEVIATION 13.99 | 32.65 kg/m^2 STANDARD_DEVIATION 10.12 |
| Degenerative Disc Disease | 2 Participants | 1 Participants | 1 Participants |
| Degenerative Joint Disease | 2 Participants | 2 Participants | 0 Participants |
| Depression | 8 Participants | 3 Participants | 5 Participants |
| Diabetes | 5 Participants | 2 Participants | 3 Participants |
| Drug Abuse | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 16 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Gastroesophaageal reflux disease (GERD) | 5 Participants | 4 Participants | 1 Participants |
| Human immunodeficiency virus infection (HIV) / Acquired immunodeficiency syndrome AIDS | 1 Participants | 1 Participants | 0 Participants |
| Hyperlipidemia | 5 Participants | 4 Participants | 1 Participants |
| Hypertension | 9 Participants | 6 Participants | 3 Participants |
| Hypothyroidism | 3 Participants | 3 Participants | 0 Participants |
| Insomnia | 2 Participants | 1 Participants | 1 Participants |
| Migraines | 6 Participants | 5 Participants | 1 Participants |
| Polycystic ovaries | 1 Participants | 1 Participants | 0 Participants |
| 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 | 27 Participants | 12 Participants | 15 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 | 16 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 2 Participants |
| Rheumatoid Arthritis | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 51 Participants | 25 Participants | 26 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Uterine Fibroids | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 7 / 26 | 8 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 |
Outcome results
Primary
12-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Population: Between the prior time point and this time point, 8 patients from the experimental group had been discharged to home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-hour Visual Analog Scale (VAS) Pain Scores | 3.9 score on a scale | Standard Deviation 3.7 |
| Experimental | 12-hour Visual Analog Scale (VAS) Pain Scores | 3.4 score on a scale | Standard Deviation 3.6 |
Primary
16-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Population: Between the prior time point and this time point, 9 patients in the control group and 2 patients from the experimental group had been discharged to home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 16-hour Visual Analog Scale (VAS) Pain Scores | 5.6 score on a scale | Standard Deviation 2.8 |
| Experimental | 16-hour Visual Analog Scale (VAS) Pain Scores | 5.4 score on a scale | Standard Deviation 2.8 |
Primary
20-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Population: Between the prior time point and this time point, 7 patients in the control group and 4 patients from the experimental group had been discharged to home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 20-hour Visual Analog Scale (VAS) Pain Scores | 5.8 score on a scale | Standard Deviation 3.4 |
| Experimental | 20-hour Visual Analog Scale (VAS) Pain Scores | 4.9 score on a scale | Standard Deviation 3.8 |
Primary
24-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Population: Between the prior time point and this time point, 4 patients in the control group and 6 patients from the experimental group had been discharged to home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 24-hour Visual Analog Scale (VAS) Pain Scores | 5.2 score on a scale | Standard Deviation 3.8 |
| Experimental | 24-hour Visual Analog Scale (VAS) Pain Scores | 8 score on a scale | Standard Deviation 1.4 |
Primary
4-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 4-hour Visual Analog Scale (VAS) Pain Scores | 5.5 score on a scale | Standard Deviation 3.5 |
| Experimental | 4-hour Visual Analog Scale (VAS) Pain Scores | 4.6 score on a scale | Standard Deviation 3.6 |
Primary
8-hour Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 8-hour Visual Analog Scale (VAS) Pain Scores | 4.4 score on a scale | Standard Deviation 3.9 |
| Experimental | 8-hour Visual Analog Scale (VAS) Pain Scores | 3.5 score on a scale | Standard Deviation 3.6 |
Primary
Initial Visual Analog Scale (VAS) Pain Scores
Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Initial Visual Analog Scale (VAS) Pain Scores | 8.3 score on a scale | Standard Deviation 1.5 |
| Experimental | Initial Visual Analog Scale (VAS) Pain Scores | 7.4 score on a scale | Standard Deviation 2.1 |
Primary
Narcotic Consumption
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
Time frame: Up to 24 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Narcotic Consumption | 36.60 Oral Morphine Equivalents (OME) | Standard Deviation 23.99 |
| Experimental | Narcotic Consumption | 23.19 Oral Morphine Equivalents (OME) | Standard Deviation 17.26 |
Secondary
12-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-hour Blood Pressure | 106.7 mmHg | Standard Deviation 8.6 |
| Experimental | 12-hour Blood Pressure | 112.0 mmHg | Standard Deviation 17.8 |
Secondary
12-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 12-hour Oxygen Saturation | 97.8 percentage of blood oxygen saturation | Standard Deviation 1.5 |
| Experimental | 12-hour Oxygen Saturation | 97.0 percentage of blood oxygen saturation | Standard Deviation 2.1 |
Secondary
16-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 16-hour Blood Pressure | 112.3 mmHg | Standard Deviation 13.6 |
| Experimental | 16-hour Blood Pressure | 104.2 mmHg | Standard Deviation 8 |
Secondary
16-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 16-hour Oxygen Saturation | 98.8 percentage of blood oxygen saturation | Standard Deviation 1.2 |
| Experimental | 16-hour Oxygen Saturation | 96.9 percentage of blood oxygen saturation | Standard Deviation 1.6 |
Secondary
20-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 20-hour Blood Pressure | 106.5 mmHg | Standard Deviation 12.5 |
| Experimental | 20-hour Blood Pressure | 114.7 mmHg | Standard Deviation 9.6 |
Secondary
20-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 20-hour Oxygen Saturation | 99.0 percentage of blood oxygen saturation | Standard Deviation 0.9 |
| Experimental | 20-hour Oxygen Saturation | 98.3 percentage of blood oxygen saturation | Standard Deviation 1.9 |
Secondary
24-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 24-hour Blood Pressure | 108.7 mmHg | Standard Deviation 8.5 |
| Experimental | 24-hour Blood Pressure | 118.3 mmHg | Standard Deviation 24.5 |
Secondary
24-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 24-hour Oxygen Saturation | 99.3 percentage of blood oxygen saturation | Standard Deviation 0.6 |
| Experimental | 24-hour Oxygen Saturation | 97.3 percentage of blood oxygen saturation | Standard Deviation 3.1 |
Secondary
4-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 4-hour Blood Pressure | 118.0 mmHg | Standard Deviation 10.8 |
| Experimental | 4-hour Blood Pressure | 119.6 mmHg | Standard Deviation 16.4 |
Secondary
4-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 4-hour Oxygen Saturation | 97.8 percentage of blood oxygen saturation | Standard Deviation 1.6 |
| Experimental | 4-hour Oxygen Saturation | 96.9 percentage of blood oxygen saturation | Standard Deviation 1.7 |
Secondary
8-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 8-hour Blood Pressure | 113.8 mmHg | Standard Deviation 12.2 |
| Experimental | 8-hour Blood Pressure | 117.9 mmHg | Standard Deviation 17.4 |
Secondary
8-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | 8-hour Oxygen Saturation | 98.7 percentage of blood oxygen saturation | Standard Deviation 1.4 |
| Experimental | 8-hour Oxygen Saturation | 96.5 percentage of blood oxygen saturation | Standard Deviation 2 |
Secondary
Initial Blood Pressure
Systolic blood pressure
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Initial Blood Pressure | 124.2 mmHg | Standard Deviation 14.8 |
| Experimental | Initial Blood Pressure | 123.8 mmHg | Standard Deviation 13.5 |
Secondary
Initial Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Initial Oxygen Saturation | 99.4 percentage of blood oxygen saturation | Standard Deviation 1.1 |
| Experimental | Initial Oxygen Saturation | 98.6 percentage of blood oxygen saturation | Standard Deviation 2.1 |
Secondary
Number of Patients Administered Anti-emetics at 4-hour Intervals
Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals
Time frame: Initial, 4, 8, 12, 16, 20, and 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 8-hours postoperatively | 2 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 16-hours postoperatively | 0 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 4-hours postoperatively | 7 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 20-hours postoperatively | 0 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 12-hours postoperatively | 4 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | 24-hours postoperatively | 0 Participants |
| Control | Number of Patients Administered Anti-emetics at 4-hour Intervals | Initial | 4 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 24-hours postoperatively | 0 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | Initial | 5 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 4-hours postoperatively | 2 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 8-hours postoperatively | 1 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 12-hours postoperatively | 0 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 16-hours postoperatively | 0 Participants |
| Experimental | Number of Patients Administered Anti-emetics at 4-hour Intervals | 20-hours postoperatively | 0 Participants |
Secondary
Rate of Wound Complications
Assessment of wound complications during any postoperative clinic visit
Time frame: 1 week to 2 months postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Rate of Wound Complications | None | 19 Participants |
| Control | Rate of Wound Complications | Minor | 5 Participants |
| Control | Rate of Wound Complications | Moderate | 2 Participants |
| Control | Rate of Wound Complications | Severe | 0 Participants |
| Experimental | Rate of Wound Complications | Severe | 1 Participants |
| Experimental | Rate of Wound Complications | None | 19 Participants |
| Experimental | Rate of Wound Complications | Moderate | 2 Participants |
| Experimental | Rate of Wound Complications | Minor | 3 Participants |
Secondary
Short-form 36-item (Sf-36) Quality of Life Questionnaire
Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.
Time frame: 1 week to 2 months postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Physical Functioning | 88.93 score on a scale | Standard Deviation 15.83 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Limitations Due to Physical Health | 82.14 score on a scale | Standard Deviation 24.86 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Limitations Due to Emotional Health | 88.10 score on a scale | Standard Deviation 28.06 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Energy/Fatigue | 54.64 score on a scale | Standard Deviation 12.63 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Emotional Well-being | 65.71 score on a scale | Standard Deviation 6.41 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Social Functioning | 92.50 score on a scale | Standard Deviation 9.71 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Pain | 59.64 score on a scale | Standard Deviation 35.84 |
| Control | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Overall General Health | 51.43 score on a scale | Standard Deviation 13.36 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Overall General Health | 56.25 score on a scale | Standard Deviation 13.69 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Physical Functioning | 90.42 score on a scale | Standard Deviation 13.98 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Emotional Well-being | 59.00 score on a scale | Standard Deviation 13.16 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Limitations Due to Physical Health | 79.17 score on a scale | Standard Deviation 32.61 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Pain | 64.42 score on a scale | Standard Deviation 25.16 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Limitations Due to Emotional Health | 80.56 score on a scale | Standard Deviation 32.04 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Social Functioning | 88.75 score on a scale | Standard Deviation 16.7 |
| Experimental | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Energy/Fatigue | 52.92 score on a scale | Standard Deviation 16.61 |