Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Inova Health Care Services

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative; Opioid Use; Colorectal Surgery; Colectomy

Treatments: Drug: Bupivacaine; Drug: Bupivacaine liposome

Study type: Interventional

Funder types: Other

Identifiers

NCT03638635

17-2725

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

Exclusion criteria

• Allergic to local anesthetics
• Unable to provide consent
• Pregnant
• On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)
• Undergoing emergent operations
• Undergoing loop ileostomy reversal
• Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

63 participants in 2 patient groups

Standard Bupivacaine

Active Comparator group

Description:

Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

Treatment:

Drug: Bupivacaine

Bupivacaine Liposome

Experimental group

Description:

Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

Treatment:

Drug: Bupivacaine liposome