Liposomal Bupivacaine in Implant Based Breast Reconstruction

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Objectives:

1. To evaluate the effect of liposomal bupivacaine on postoperative pain levels.

2. To evaluate the effect of liposomal bupivacaine on postoperative opioid consumption and opioid related adverse events.

3. To evaluate the effect of liposomal bupivacaine on length of hospital stay.

4. To evaluate the effect of liposomal bupivacaine on patient satisfaction with postoperative pain control.

5. To evaluate the effect of liposomal bupivacaine on overall patient satisfaction.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Bupivacaine; Diazepam; Epinephrine; Epinephryl borate; Hydrocodone; Morphine; Oxycodone; Racepinephrine

Criteria

Inclusion Criteria:

• Women undergoing immediate unilateral or bilateral tissue-expander breast reconstruction following skin-sparing or nipple-sparing mastectomy

Exclusion Criteria:

• Women who are unable to give informed consent to participate in this study

• Women with a documented history of hypersensitivity reactions to local-anesthetic agents

• Women with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety

• Women who are currently pregnant

• Women undergoing tissue expander based breast reconstruction with a muscle flap in combination with a tissue expander

• Women with impaired hepatic function