Clinical trial NCT02222129: Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery
Official title: A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Randomized controlled trial
anesthetics-local
bupivacaine
analgesia
Pain, Postoperative
Lead sponsor: Knight, Richard, M.D.
Sponsor class: INDIV
First posted: 2014-08-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.

Detailed description: Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.

Eligibility criteria: Inclusion Criteria:

* At least 18-years-old, undergoing laparoscopic urologic surgery.

Exclusion Criteria:

* Pregnant and/or nursing mothers.
* Allergy to bupivacaine.

Primary outcomes:
measure: Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
timeFrame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Secondary outcomes:
measure: Visual Analog Pain Scores.
timeFrame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
measure: Length of Hospital Stay.
timeFrame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
measure: Time to First Opioid Use.
timeFrame: All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Baptist Health System
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System
state: Texas
Study officials:
affiliation: San Antonio Uniformed Services Health Education Consortium
name: Richard B Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: