Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial

Conditions
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Pain, Postoperative, Mammaplasty

Intervention / Treatment
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* Drug: Dexamethasone 4mg
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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. | Drug: Saline<br>* The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.<br>|
| Experimental: Experimental<br>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. | Drug: Dexamethasone 4mg<br>* The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | Up to 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial Blood Pressure | Systolic blood pressure | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) | 
| 4-hour Blood Pressure | Systolic blood pressure | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 8-hour Blood Pressure | Systolic blood pressure | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 12-hour Blood Pressure | Systolic blood pressure | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 16-hour Blood Pressure | Systolic blood pressure | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 20-hour Blood Pressure | Systolic blood pressure | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 24-hour Blood Pressure | Systolic blood pressure | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| Initial Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) | 
| 4-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 8-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 12-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 16-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 20-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) | 
| 24-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | 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 | 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. | 1 week to 2 months postoperatively | 
| Rate of Wound Complications | Assessment of wound complications during any postoperative clinic visit | 1 week to 2 months postoperatively |