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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Temple University Hospital
Philadelphia, Pennsylvania, United States
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)
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)
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)
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)
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)
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)
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)
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Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Narcotic Consumption
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
Time frame: Up to 24 hours postoperatively
Initial Blood Pressure
Systolic blood pressure
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
4-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
8-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
12-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
16-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
20-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
24-hour Blood Pressure
Systolic blood pressure
Time frame: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Initial Oxygen Saturation
SpO2 as measured by pulse oximetry
Time frame: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
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)
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)
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)
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)
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)
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)
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
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
Rate of Wound Complications
Assessment of wound complications during any postoperative clinic visit
Time frame: 1 week to 2 months postoperatively