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

Henry Ford Health

Status and phase: Completed; Phase 4

Conditions: Hysterectomy

Treatments: Drug: Liposomal bupivacaine; Drug: Saline; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03250507

IRB 10655

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion criteria

• Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Bupivacaine

Active Comparator group

Description:

Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine

Treatment:

Drug: Bupivacaine

Liposomal bupivacaine

Active Comparator group

Description:

Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine.

Treatment:

Drug: Saline

Drug: Liposomal bupivacaine

Liposomal bupivacaine and bupivacaine

Experimental group

Description:

Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine.

Treatment:

Drug: Bupivacaine

Drug: Liposomal bupivacaine