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NCT Number: NCT02805504

Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

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.

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Key information

Conditions

Urinary Tract Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loma Linda Medical Center

Loma Linda, California, 92350, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel

Drug

This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.

Other names: liposomal bupivacaine

marcaine

Drug

This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Other names: Bupivacaine HCl

Primary outcomes

  1. Total Opioid Consumption

    Time frame: Postoperative days 1-3

    Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively

  2. Postoperative Pain Assessment

    Time frame: Postoperative day 1

    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.

  3. Length of Hospital Stay

    Time frame: Duration of stay in hours

    Duration of hospital stay after the surgery until time of discharge

  4. Postoperative Complications

    Time frame: 30 days postoperatively

    Any complication related to the surgery within 30 days

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2016
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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