Urinary Tract DiseasesPhase 4NCT02805504

Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

A Phase 4 study testing Exparel and Marcaine in people with Urinary Tract Diseases, run by Loma Linda University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Tract Diseases
What is being tested?: Exparel and Marcaine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2016to 9 May 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing urologic surgery.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda Medical Center
Loma Linda, California, 92350

Other trials in United States

About this study

Official title: Efficacy of the 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.

Read the detailed description

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

Conditions: Urinary Tract Diseases
Being tested: Exparel, Marcaine
Keywords: Bupivacaine, Minimally Invasive Surgical Procedures
Medical subject headings: Urologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExparelDrug
Also called liposomal bupivacaine
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
MarcaineDrug
Also called Bupivacaine HCl
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Study groups in NCT02805504
Study group	Role	What they receive
Exparel	Experimental	This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. Receives: Drug: Exparel
Marcaine	Active comparator	This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. Receives: Drug: Marcaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Opioid Consumption
Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively
Measured: Postoperative days 1-3
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.
Measured: Postoperative day 1
Length of Hospital Stay
Duration of hospital stay after the surgery until time of discharge
Measured: Duration of stay in hours
Postoperative Complications
Any complication related to the surgery within 30 days
Measured: 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 20169 May 2022

First posted20 Jun 2016 (estimated)
Study start11 Jul 2016
Primary completion9 May 2022
Study completion9 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Urinary Tract DiseasesStudies of the same condition, open and under way.
More trials run by Loma Linda UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02805504
Sponsor's protocol ID: 5160165
Status last verified: Mar 2024
First submitted: 14 Jun 2016
Last updated: 24 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26307232
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.
PubMed 26056753
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.
PubMed 25940854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Urinary Tract Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
ClinicalTrials.gov ID: NCT02805504
Acronym / sponsor ID: 5160165
Conditions: Urinary Tract Diseases
Keywords: Bupivacaine, Minimally Invasive Surgical Procedures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 11 Jul 2016 (actual)
Primary completion: 9 May 2022 (actual)
Study completion: 9 May 2022 (actual)
First posted: 20 Jun 2016 (estimated)
Results: Posted 24 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Exparel	Experimental	Drug: ExparelThis arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Marcaine	Active comparator	Drug: MarcaineThis group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing urologic surgery.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExparelAlso: liposomal bupivacaineThis group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.	Drug	Exparel
MarcaineAlso: Bupivacaine HClThis group will receive intraoperative Bupivacaine HCl injection at the surgical site.	Drug	Marcaine

Primary outcome

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
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.
Length of Hospital Stay
Time frame: Duration of stay in hours
Duration of hospital stay after the surgery until time of discharge
Postoperative Complications
Time frame: 30 days postoperatively
Any complication related to the surgery within 30 days

Results and safety

Results posted to the registry on 24 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exparel	63	63
Marcaine	73	73

Primary outcome: Total Opioid Consumption

Time frame: Postoperative days 1-3. Mean (Standard Deviation). Unit: morphine equivalent

Measure	Exparel n = 53	Marcaine n = 55
Value	16.4 (19.4)	15.3 (16.2)

Population analysed: During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.

Primary outcome: Postoperative Pain Assessment

Time frame: Postoperative day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Exparel n = 53	Marcaine n = 55
Value	4.6 (2.1)	4.6 (2.4)

Primary outcome: Length of Hospital Stay

Time frame: Duration of stay in hours. Mean (Standard Deviation). Unit: Hours

Measure	Exparel n = 53	Marcaine n = 55
Value	37 (31.8)	36 (24)

Primary outcome: Postoperative Complications

Time frame: 30 days postoperatively. Count of participants. Unit: Participants

Measure	Exparel n = 53	Marcaine n = 55
Value	6	6

Adverse events

Time frame: 30-days postoperatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exparel	6 of 63 (9.5%)	0 of 63 (0%)	0 of 63
Marcaine	6 of 73 (8.2%)	0 of 73 (0%)	0 of 73

Limitations and caveats (from the sponsor): During an audit by the compliance department of Loma Linda University, it was noted that some consents were incomplete and therefore could not undergo further analysis. Data presented has been taken from abstracts with preliminary analyses presented prior to the audit and subsequently should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26307232Abdelsattar 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.
Background: PubMed 26056753Hutchins 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.
Background: PubMed 25940854White 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Keheila, MD study director

Loma Linda University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exparel and Marcaine in people with Urinary Tract Diseases, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Opioid Consumption (time frame: Postoperative days 1-3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02805504, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.