NCT03638635

Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Detailed description

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects. Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively). In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Conditions

• Opioid Use
• Pain, Postoperative
• Colectomy
• Colorectal Surgery

Interventions

Type	Name	Description
DRUG	Bupivacaine	Abdominal injection of bupivacaine into fascial layer.
DRUG	Bupivacaine liposome	Abdominal injection of bupivacaine liposome into fascial layer.

Timeline

• Start date: 2018-05-14
• Primary completion: 2019-01-16
• Completion: 2019-01-16
• First posted: 2018-08-20
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study