Phase 2
Completed N=56
Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty
Pain, Postoperative · Mammaplasty
Source: ClinicalTrials.gov NCT04919317 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Initial Visual Analog Scale (VAS) Pain Scores — 8.3; 7.4 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial Visual Analog Scale (VAS) Pain Scores |
8.3; 7.4 | — |
| PRIMARY 4-hour Visual Analog Scale (VAS) Pain Scores |
5.5; 4.6 | — |
| PRIMARY 8-hour Visual Analog Scale (VAS) Pain Scores |
4.4; 3.5 | — |
| PRIMARY 12-hour Visual Analog Scale (VAS) Pain Scores |
3.9; 3.4 | — |
| PRIMARY 16-hour Visual Analog Scale (VAS) Pain Scores |
5.6; 5.4 | — |
| PRIMARY 20-hour Visual Analog Scale (VAS) Pain Scores |
5.8; 4.9 | — |
| PRIMARY 24-hour Visual Analog Scale (VAS) Pain Scores |
5.2; 8 | — |
| PRIMARY Narcotic Consumption |
36.60; 23.19 | — |
| SECONDARY Initial Blood Pressure |
124.2; 123.8 | — |
| SECONDARY 4-hour Blood Pressure |
118.0; 119.6 | — |
| SECONDARY 8-hour Blood Pressure |
113.8; 117.9 | — |
| SECONDARY 12-hour Blood Pressure |
106.7; 112.0 | — |
| SECONDARY 16-hour Blood Pressure |
112.3; 104.2 | — |
| SECONDARY 20-hour Blood Pressure |
106.5; 114.7 | — |
| SECONDARY 24-hour Blood Pressure |
108.7; 118.3 | — |
| SECONDARY Initial Oxygen Saturation |
99.4; 98.6 | — |
| SECONDARY 4-hour Oxygen Saturation |
97.8; 96.9 | — |
| SECONDARY 8-hour Oxygen Saturation |
98.7; 96.5 | — |
| SECONDARY 12-hour Oxygen Saturation |
97.8; 97.0 | — |
| SECONDARY 16-hour Oxygen Saturation |
98.8; 96.9 | — |
| SECONDARY 20-hour Oxygen Saturation |
99.0; 98.3 | — |
| SECONDARY 24-hour Oxygen Saturation |
99.3; 97.3 | — |
| SECONDARY Number of Patients Administered Anti-emetics at 4-hour Intervals |
4; 5; 7; 2; 2; 1 | — |
| SECONDARY Short-form 36-item (Sf-36) Quality of Life Questionnaire |
88.93; 90.42; 82.14; 79.17; 88.10; 80.56 | — |
| SECONDARY Rate of Wound Complications |
19; 19; 5; 3; 2; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04919317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.