Postoperative PainPhase 4NCT02287246
Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Urogynecologic Surgery
A Phase 4 study testing Extended-Release liposomal bupivacaine (Exparel) and Normal saline in people with Postoperative Pain, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Extended-Release liposomal bupivacaine (Exparel) and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis (including but not limited to posterior colporrhaphy, colpocleisis, sphincter repair, sphincteroplasty, perineoplasty) at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available.
Who cannot join
- Known allergy to amide local anesthetics Unstable cardiac arrhythmia Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer) Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable) Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery Significant history of opioid or alcohol abuse or addiction (requiring treatment) Concurrent pain management requiring the use of epidural anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Christina Jones, DO, 301-400-2468, christina.l.jones50.mil@mail.mil
About this study
Official title: Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Pain Management Following Urogynecologic Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.
Read the detailed description
Effective post-operative pain management is a crucial component of a patient's surgical course following Urogynecologic surgery. Narcotics are the cornerstone for post-operative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks5. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, this medication has not yet been reported within Urogynecology literature.
We propose a prospective, randomized, double blind, placebo controlled trial with 120 subjects recruited from the WRNMMC Urogynecology Clinic to study post-operative efficacy of Exparel® for pain control in patients undergoing Urogynecology surgery involving the posterior vaginal wall. Subjects will be randomized to receive either 20mL of extended-release bupivacaine or 20mL placebo.
The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.
Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.
- Conditions
- Postoperative Pain
- Being tested
- Extended-Release liposomal bupivacaine (Exparel), Normal saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release liposomal bupivacaine (Exparel)Drug
Also called Exparel
20mL
Normal salineDrug
20mL
| Study group | Role | What they receive |
|---|---|---|
| Extended-Release liposomal bupivacaine | Experimental | 20mL Extended-release liposomal bupivacaine injected into the posterior vaginal wall following surgery Receives: Drug: Extended-Release liposomal bupivacaine (Exparel) |
| Placebo (normal saline) | Active comparator | 20mL normal saline injected into the posterior vaginal wall following surgery Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative post-operative pain control
The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.
Measured: Post operative day 1 and 3
Secondary outcomes (1)
Evaluate vaginal pain on Post-operative day 7
Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.
Measured: Post-operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Christy Jones, Walter Reed National Military Medical Center
- Investigators
- Christin L Jones, DO, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287246
- Sponsor's protocol ID
- 399635
- Status last verified
- May 2016
- First submitted
- 5 Nov 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Planning to publish once completed
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extended-Release Liposomal Bupivacaine for Post-Operative Pain Management Following Urogynecologic Surgery: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02287246
- Acronym / sponsor ID
- 399635
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Oct 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study post-operative efficacy of Exparel® for pain control in patients undergoing any Urogynecology surgery involving the posterior vaginal wall using a randomized, double-blinded placebo controlled trial.
Detailed description
Effective post-operative pain management is a crucial component of a patient's surgical course following Urogynecologic surgery. Narcotics are the cornerstone for post-operative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks5. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, this medication has not yet been reported within Urogynecology literature.
We propose a prospective, randomized, double blind, placebo controlled trial with 120 subjects recruited from the WRNMMC Urogynecology Clinic to study post-operative efficacy of Exparel® for pain control in patients undergoing Urogynecology surgery involving the posterior vaginal wall. Subjects will be randomized to receive either 20mL of extended-release bupivacaine or 20mL placebo.
The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.
Additional objectives of this study are to evaluate vaginal pain on post-operative day 7, total medication usage on days 1, 3 and 7 and any post-operative voiding dysfunction, comparing the study group to the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-Release liposomal bupivacaine | Experimental | Drug: Extended-Release liposomal bupivacaine (Exparel)20mL Extended-release liposomal bupivacaine injected into the posterior vaginal wall following surgery |
| Placebo (normal saline) | Active comparator | Drug: Normal saline20mL normal saline injected into the posterior vaginal wall following surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis (including but not limited to posterior colporrhaphy, colpocleisis, sphincter repair, sphincteroplasty, perineoplasty) at Walter Reed National Military Medical Center. Patients must be able to read and understand written English or have an appropriate certified medical translator available.
Key exclusion criteria (1 listed)
- Known allergy to amide local anesthetics Unstable cardiac arrhythmia Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer) Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable) Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery Significant history of opioid or alcohol abuse or addiction (requiring treatment) Concurrent pain management requiring the use of epidural anesthesia
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 |
|---|---|---|
| Extended-Release liposomal bupivacaine (Exparel)Also: Exparel20mL | Drug | Extended-Release liposomal bupivacaine |
| Normal saline20mL | Drug | Placebo (normal saline) |
Primary outcome
Cumulative post-operative pain control
Time frame: Post operative day 1 and 3
The primary objective of the trial will be to evaluate the cumulative post-operative vaginal pain using front side of Defense and Veterans Pain Rating Scale16 at days 1 and 3 post-procedure.. We hypothesize a 30% difference in post-operative pain measurements between the active medication group and placebo group.
1 secondary outcome
Evaluate vaginal pain on Post-operative day 7
Time frame: Post-operative day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: Yes. Planning to publish once completed
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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.
Christin L Jones, DO principal investigator
WRNMMC
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 Extended-Release liposomal bupivacaine (Exparel) and Normal saline in people with Postoperative Pain, run by Walter Reed National Military Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 24 May 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina L Jones, DO (301-400-2468, christina.l.jones50.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative post-operative pain control (time frame: Post operative day 1 and 3). 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 24 May 2016.