Urinary Incontinence, StressPhase 4NCT02296099
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
A Phase 4 study testing liposomal bupivacaine in people with Urinary Incontinence, Stress, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults greater than 18 years of age
- Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia
Who cannot join
- Pregnant or nursing
- Allergy to bupivacaine
- History of drug/alcohol abuse
- Severe cardiovascular, hepatic, renal disease, or neurological impairment
- Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
- Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)
Show all 10Show fewer
- Administration of an investigational drug within 30 days before study
- Chronic pain syndromes
- Daily NSAID/opioid use
- Patients having concomitant procedures or not undergoing general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
Read the detailed description
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- liposomal bupivacaine, Placebo
- Keywords
- retropubic suburethral sling, stress urinary incontinence, liposomal bupivacaine
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaineDrug
Also called Exparel
Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
PlaceboDrug
Also called Normal Saline
Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Experimental | The placement of the retropublic sling will be placed in routine fashion under general anesthesia. If randomized to liposomal bupivacaine, the standard 20 milliliter (ml) vial (266mg dose) will be diluted with 10ml of preservative-free, sterile normal saline (0.9%) for injection to a reconstituted volume of 30ml. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have the 30ml dilutional volume injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. Receives: Drug: liposomal bupivacaine |
| Saline Placebo | Placebo comparator | The placement of the retropublic sling will be placed in routine fashion under general anesthesia. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the saline placebo arm will receive 30ml normal saline injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in the Morning
A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Measured: Day 1
Secondary outcomes (5)
Pain Upon Discharge From Post-anesthesia Care Unit (PACU)
A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Measured: 1 day
Pain Upon Discharge From Same Day Surgery
A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Measured: 1 day
Pain at Four Hours After Discharge Home
A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
Measured: 1 day, 4 hours after discharge from Same Day Surgery
Total Narcotic Consumption
Cumulative consumption postoperative days 1 - 3
Measured: Day 1 - 3
Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit
A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 2016
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.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrina Crisp, MD, MSc, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296099
- Sponsor's protocol ID
- 14-052
- Status last verified
- Feb 2018
- First submitted
- 18 Nov 2014
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02296099
- Acronym / sponsor ID
- 14-052
- Conditions
- Urinary Incontinence, Stress
- Keywords
- retropubic suburethral sling, stress urinary incontinence, liposomal bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 5 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
Detailed description
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Drug: liposomal bupivacaineThe placement of the retropublic sling will be placed in routine fashion under general anesthesia. If randomized to liposomal bupivacaine, the standard 20 milliliter (ml) vial (266mg dose) will be diluted with 10ml of preservative-free, sterile normal saline (0.9%) for injection to a reconstituted volume of 30ml. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have the 30ml dilutional volume injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. |
| Saline Placebo | Placebo comparator | Drug: PlaceboThe placement of the retropublic sling will be placed in routine fashion under general anesthesia. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the saline placebo arm will receive 30ml normal saline injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults greater than 18 years of age
- Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia
Key exclusion criteria (10 listed)
- Pregnant or nursing
- Allergy to bupivacaine
- History of drug/alcohol abuse
- Severe cardiovascular, hepatic, renal disease, or neurological impairment
- Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
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 |
|---|---|---|
| liposomal bupivacaineAlso: ExparelLiposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally. | Drug | Liposomal Bupivacaine |
| PlaceboAlso: Normal SalineNormal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally. | Drug | Saline Placebo |
Primary outcome
Pain in the Morning
Time frame: Day 1
A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.
5 secondary outcomes
Pain Upon Discharge From Post-anesthesia Care Unit (PACU)
Time frame: 1 day
Pain Upon Discharge From Same Day Surgery
Time frame: 1 day
Pain at Four Hours After Discharge Home
Time frame: 1 day, 4 hours after discharge from Same Day Surgery
Total Narcotic Consumption
Time frame: Day 1 - 3
Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Catrina Crisp, MD, MSc principal investigator
TriHealth Inc.
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 liposomal bupivacaine in people with Urinary Incontinence, Stress, run by TriHealth Inc. 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 2 inclusion and 10 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 16 Aug 2018. 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. Some participants in this study may receive a placebo. 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 5 Mar 2018). 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?
Pain in the Morning (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.