Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Mammaplasty
• Intervention / Treatment: Drug: Saline; Drug: Dexamethasone 4mg

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Andrew A Gassman, MD, FACS, Lewis Katz School of Medicine at Temple University

Publications and helpful links

General Publications

• Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
• Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4.
• Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18.
• Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17.
• Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149.
• Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
• Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): November 7, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 24361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available to other researchers if necessary
• IPD Sharing Time Frame: 6 months after any potential publications from this study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes