Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

NCT04919317 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 24361
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Mammaplasty

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (17)

• Initial Blood Pressure

  Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

• 4-hour Blood Pressure

  Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

• 8-hour Blood Pressure

  Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

• 12-hour Blood Pressure

  Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

• 16-hour Blood Pressure

  Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

Study Arms (2)

Control

PLACEBO COMPARATOR

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

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

Interventions

Dexamethasone 4mg DRUG

The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

Experimental

Saline DRUG

The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (8)

• 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.

  PMID: 8880841 BACKGROUND

• 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.

  PMID: 27043853 BACKGROUND

• 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.

  PMID: 31741068 BACKGROUND

• 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.

  PMID: 22939099 BACKGROUND

• 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.

  PMID: 31303703 BACKGROUND

• 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.

  PMID: 27473629 BACKGROUND

• 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.

  PMID: 28033159 BACKGROUND

• 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.

  PMID: 30066465 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Single-center study, which may limit the generalizability of the results The patient population is predominantly composed of racial minority communities, which may also limit the generalizability to many institutions Low SF-36 completion limited an adequate determination of the effects of the block on quality of life metrics. Some SF-36 questionnaires were completed by phone interview The COVID-19 pandemic halted enrollment for four months, which may have imposed a selection bias

Results Point of Contact

• Title: George Taylor, MD, MS; surgical resident
• Organization: Temple University Hospital

George.Taylor@tuhs.temple.edu

2678150512

Study Officials

• Andrew A Gassman, MD, FACS

  Lewis Katz School of Medicine at Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 9, 2021
• Study Start: September 29, 2017
• Primary Completion: November 7, 2020
• Study Completion: November 25, 2020
• Last Updated: October 11, 2023
• Results First Posted: July 13, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months after any potential publications from this study

Locations

US (1)