Phase 4
Completed N=50
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Pain, Postoperative · Mammaplasty
Source: ClinicalTrials.gov NCT04278846 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: 1 Hour Pain Assessment Numeric Rating Scale During Rest — 5; 5 units on a scale — p=.87
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1 Hour Pain Assessment Numeric Rating Scale During Rest |
5; 5 | .87 |
| PRIMARY 8-12 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 3 | .49 |
| PRIMARY 24 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 3.5 | .57 |
| PRIMARY 36 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 3 | .3 |
| PRIMARY 48 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 3 | .99 |
| PRIMARY 60 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 2 | .33 |
| PRIMARY 72 Hour Pain Assessment Numeric Rating Scale During Rest |
3; 2 | .26 |
| PRIMARY 84 Hour Pain Assessment Numeric Rating Scale During Rest |
1; 2 | .79 |
| PRIMARY 96 Hour Pain Assessment Numeric Rating Scale During Rest |
1.5; 2 | .62 |
| PRIMARY 36 Hour Pain Assessment Numeric Rating Scale During Activity |
5; 5 | .94 |
| PRIMARY 48 Hour Pain Assessment Numeric Rating Scale During Activity |
4; 5 | .95 |
| PRIMARY 60 Hour Pain Assessment Numeric Rating Scale During Activity |
5; 4 | .54 |
| PRIMARY 72 Hour Pain Assessment Numeric Rating Scale During Activity |
4; 4 | .95 |
| PRIMARY 84 Hour Pain Assessment Numeric Rating Scale During Activity |
4; 3 | .96 |
| PRIMARY 96 Hour Pain Assessment Numeric Rating Scale During Activity |
3.5; 3 | — |
| PRIMARY 24 Hour Pain Assessment Brief Pain Inventory |
4; 5 | .088 |
| PRIMARY 48 Hour Pain Assessment Brief Pain Inventory |
3.5; 4 | .42 |
| PRIMARY 72 Hour Pain Assessment Brief Pain Inventory |
3; 3 | .88 |
| PRIMARY 96 Hour Pain Assessment Brief Pain Inventory |
3; 2 | — |
| PRIMARY 96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction |
0; 1; 0; 0; 0; 2 | .12 |
| SECONDARY 24 Hour Use of Rescue Analgesic |
63.3; 63.9 | .96 |
| SECONDARY 48 Hour Use of Rescue Analgesic |
25.1; 23.3 | .76 |
| SECONDARY 72 Hour Use of Rescue Analgesic |
20.7; 19.9 | .88 |
| SECONDARY 96 Hour Use of Rescue Analgesic |
10.2; 7.5 | .37 |
Eligibility Criteria
Inclusion Criteria
- undergoing breast reconstruction with tissue expander
Exclusion Criteria
- history of adverse reaction to local anesthesia
- chronic liver disease
- history of chronic preoperative consumption of narcotics or opioids
- history of alcohol and/or illicit drug dependence
- undergoing combined procedures
- diagnosed with neuromuscular/neurosensory disorder
- positive pregnancy test
- previous breast conservation therapy (lumpectomy with radiation treatment
- previous surgeries or trauma in the breast or chest region (denervation may bias pain perception)
- axillary node dissection
- psychosis.
Data sourced from ClinicalTrials.gov (NCT04278846). 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.