NCT04278846

Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fifty consecutive (25 per arm) patients undergoing unilateral or bilateral breast reconstruction with tissue expanders will be administered intraoperatively in a standardized manner with either bupivicaine HCl (control group) or liposomal bupivacaine/Exparel (experimental group). Pain will be assessed qualitatively through the use of: 1) numeric rating scale during rest (NRS-R) and activity (NRS-A), 2) brief pain inventory (BPI) questionnaire, and 3) postoperative analgesia patient satisfaction scale. Furthermore, investigators will record the use of rescue analgesics for each patient. This part of the study will provide quantitative data that investigators can then use in comparison to the qualitative measurements (NSR, BPI, patient satisfaction scale rate). In turn, this will allow us to objectify patient's pain, thereby increasing the validity of our results. More importantly, this aspect of the investigation will enable us to study the impact that liposomal bupivacaine has in reducing the postoperative usage of opioid medications in this patient population. As this is a pilot study, a sample size of 50 total patients (25 per treatment group) is planned. This sample size should provide estimates of potential effect sizes and variability in the present setting to allow for future study planning. This study should provide adequate evidence of whether pain decreases of 15% or more are unlikely in this setting. Investigators aim to evaluate the effectiveness of DepoFoam Bupivicaine (Exparel®) to reduce postoperative pain in breast reconstruction patients compared to the current standard treatment (bupivacaine HCl). Investigators hypothesize that patients undergoing breast reconstruction with tissue expander will achieve greater control of post-operative pain and longer lasting analgesia with the use of liposomal bupivacaine.

Conditions

• Pain, Postoperative
• Mammaplasty

Interventions

Type	Name	Description
DRUG	Depofoam bupivacaine	The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
DRUG	Bupivacaine hydrochloride (HCl)	The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Timeline

• Start date: 2014-08-22
• Primary completion: 2017-12-31
• Completion: 2019-05-15
• First posted: 2020-02-20
• Last updated: 2022-07-01
• Results posted: 2022-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study