Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

Phase 2

Completed

Conditions: Mammaplasty
Pain, Postoperative

Interventions: Drug: Dexamethasone 4mg
Drug: Saline

Registration Number: NCT04919317

Lead Sponsor: Temple University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 56

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Dexamethasone 4mg	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.
Control	Saline	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.

Primary Outcome Measures

Name	Time	Method
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)
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)
Narcotic Consumption	Up to 24 hours postoperatively	Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
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)
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)
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)

Secondary Outcome Measures

Name	Time	Method
24-hour Blood Pressure	Recorded at 24-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
20-hour Blood Pressure	Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)	Systolic blood pressure
Initial Blood Pressure	Recorded immediately upon 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
Initial Oxygen Saturation	Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)	SpO2 as measured by pulse oximetry
12-hour Blood Pressure	Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)	Systolic blood pressure
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
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
4-hour Blood Pressure	Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)	Systolic blood pressure
4-hour Oxygen Saturation	Recorded at 4-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
20-hour Oxygen Saturation	Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)	SpO2 as measured by pulse oximetry
24-hour Oxygen Saturation	Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)	SpO2 as measured by pulse oximetry