Clinical trial NCT02805504: Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Official title: Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Diseases
Keywords: Bupivacaine
Minimally Invasive Surgical Procedures
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 136
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 controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

Detailed description: A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:

The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection

Primary Outcome Measures:

* Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay
* Postoperative pain assessment using visual Analog Pain Scores \& Brief Pain Inventory form.
* Length of Hospital Stay
* Time to First Opioid Use.
* Postoperative Constipation , paralytic ileus

Eligibility criteria: Inclusion Criteria:

* Patients undergoing urologic surgery.

Exclusion Criteria:

* Pregnant and/or nursing mothers.
* Allergy to bupivacaine.
* History of drug/alcohol abuse.
* Severe cardiovascular, hepatic, renal disease or neurological impairment.

Primary outcomes:
measure: Total Opioid Consumption
timeFrame: Postoperative days 1-3
measure: Postoperative Pain Assessment
timeFrame: Postoperative day 1
measure: Length of Hospital Stay
timeFrame: Duration of stay in hours
measure: Postoperative Complications
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Mohamed Keheila, MD
role: STUDY_DIRECTOR
References:
citation: Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.
citation: Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
citation: White S, Vaughan C, Raiff D, Eward W, Bolognesi M. Impact of liposomal bupivacaine administration on postoperative pain in patients undergoing total knee replacement. Pharmacotherapy. 2015 May;35(5):477-81. doi: 10.1002/phar.1587. Epub 2015 May 4.