Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Urinary Tract Diseases Clinical Trial

Official title:

Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805504
• Other study ID #: 5160165
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2016
• Est. completion date: May 9, 2022

Study information

• Verified date: March 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Urinary Tract Diseases
• Urologic Diseases

Intervention

Drug:
• Exparel
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
• Marcaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Locations

Country	Name	City	State
United States	Loma Linda Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption	Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively	Postoperative days 1-3
Primary	Postoperative Pain Assessment	Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.	Postoperative day 1
Primary	Length of Hospital Stay	Duration of hospital stay after the surgery until time of discharge	Duration of stay in hours
Primary	Postoperative Complications	Any complication related to the surgery within 30 days	30 days postoperatively