NCT03250507

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Detailed description

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

Conditions

• Hysterectomy

Interventions

Type	Name	Description
DRUG	Bupivacaine	0.25% bupivacaine for TAP block
DRUG	Liposomal bupivacaine	Exparel for TAP block
DRUG	Saline	Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

Timeline

• Start date: 2017-03-13
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2017-08-15
• Last updated: 2022-12-21
• Results posted: 2022-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study