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Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

Primary Purpose

Pain, Postoperative, Mammaplasty

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone 4mg
Saline
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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)
Narcotic Consumption
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization

Secondary Outcome Measures

Initial Blood Pressure
Systolic blood pressure
4-hour Blood Pressure
Systolic blood pressure
8-hour Blood Pressure
Systolic blood pressure
12-hour Blood Pressure
Systolic blood pressure
16-hour Blood Pressure
Systolic blood pressure
20-hour Blood Pressure
Systolic blood pressure
24-hour Blood Pressure
Systolic blood pressure
Initial Oxygen Saturation
SpO2 as measured by pulse oximetry
4-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
8-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
12-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
16-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
20-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
24-hour Oxygen Saturation
SpO2 as measured by pulse oximetry
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
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.
Rate of Wound Complications
Assessment of wound complications during any postoperative clinic visit

Full Information

First Posted
May 21, 2021
Last Updated
October 8, 2023
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT04919317
Brief Title
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Official Title
Enhanced Pain Control After Reduction Mammaplasty With Bupivicaine and Dexamethasone Regional Block: a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
November 7, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Mammaplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 4mg
Intervention Description
The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
Primary Outcome Measure Information:
Title
Initial Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
4-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
8-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
12-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
16-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
20-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
24-hour Visual Analog Scale (VAS) Pain Scores
Description
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)
Title
Narcotic Consumption
Description
Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization
Time Frame
Up to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Initial Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Title
4-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
8-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
12-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
16-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
20-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
24-hour Blood Pressure
Description
Systolic blood pressure
Time Frame
Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
Initial Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
Title
4-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
8-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
12-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
16-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
20-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
24-hour Oxygen Saturation
Description
SpO2 as measured by pulse oximetry
Time Frame
Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)
Title
Number of Patients Administered Anti-emetics at 4-hour Intervals
Description
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
Title
Short-form 36-item (Sf-36) Quality of Life Questionnaire
Description
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
Title
Rate of Wound Complications
Description
Assessment of wound complications during any postoperative clinic visit
Time Frame
1 week to 2 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew A Gassman, MD, FACS
Organizational Affiliation
Lewis Katz School of Medicine at Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
8880841
Citation
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.
Results Reference
background
PubMed Identifier
27043853
Citation
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.
Results Reference
background
PubMed Identifier
31741068
Citation
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.
Results Reference
background
PubMed Identifier
22939099
Citation
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.
Results Reference
background
PubMed Identifier
31303703
Citation
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.
Results Reference
background
PubMed Identifier
27473629
Citation
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.
Results Reference
background
PubMed Identifier
28033159
Citation
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.
Results Reference
background
PubMed Identifier
30066465
Citation
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.
Results Reference
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Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

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