Postoperative PainPhase 4NCT03875664
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
A Phase 4 study testing Liposomal bupivacaine in people with Postoperative Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for… 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?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 31 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse
Who cannot join
- Planned regional anesthesia
- Allergy or contraindication to bupivacaine
- Allergy or contraindication to opioids
- Allergy or contraindication to non-steroidal medications
- Planned laparotomy
- Chronic pain diagnosis and/or chronic narcotic use
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Center for Pelvic Health
Charlotte, North Carolina, 28207
About this study
Official title: Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.
Read the detailed description
Liposomal bupivacaine (EXPAREL; Pacira Pharmaceuticals, San Diego, CA) is an extended release local anesthetic approved by the Food and Drug Administration since 2011 for the treatment of postsurgical pain. It is a multivesicular liposomal delivery system, consisting of a liquid bupivacaine core encapsulated by a phospholipid shell. This delivery technology allows for the slow, sustained release of bupivacaine over at least 72 hours.
Liposomal bupivacaine has been studied extensively in the general surgery and orthopedic surgery literature. Specifically, infiltration of liposomal bupivacaine after excisional hemorrhoidectomy has been shown to significantly lower postsurgical pain scores, decrease total postoperative opioid requirements, increase the number of patients who do not require any opioids after surgery, meaningfully delay the median time to first opioid use, and improve patient satisfaction with overall perioperative analgesia.
Posterior colporrhaphy and perineorrhaphy are pelvic reconstructive surgical procedures that are associated with significant postsurgical localized pain resulting from surgical incisions. Investigators hypothesize this localized postsurgical pain will benefit from treatment with an extended release local anesthetic formulation similar to hemorrhoidectomy. Intraoperative infiltration of a standard local anesthetic during posterior repair and perineorrhaphy has been shown to improve early analgesia and facilitate early postoperative recovery. These findings reiterate the need for studies investigating a slow-release, longer-acting local anesthetic formulation for patients undergoing posterior repair and/or perineorrhaphy - one that ideally can be integrated into an evidence-based, opioid-sparing postsurgical pain management regimen to improve perioperative care for the steadily growing pelvic reconstructive surgical patient population.
The primary study objective is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS).
Secondary objectives include to evaluate total opioid consumption during the first 72 postoperative hours, to evaluate patient satisfaction with postoperative analgesia, to evaluate time to first opioid administration postoperatively, to evaluate hospital length of stay, to evaluate length of stay in post-anesthesia care unit (PACU), to evaluate total hospital costs, to evaluate time to first bowel movement postoperatively, to evaluate rate of postoperative nausea and vomiting, to evaluate time to successful voiding trial, and to evaluate proportion of patients discharged home with a Foley catheter.
Patients will be approached for participation preoperatively and randomized in the operating room to either liposomal bupivacaine or injectable normal saline administered into the posterior vaginal compartment in a standardized technique. All concurrent minimally invasive pelvic reconstructive surgical procedures are allowed. Randomization will be stratified for abdominal versus purely vaginal surgery. Perioperative care is standardized. Data will be abstracted from the medical record. Additionally, subjects will be discharged home with a medication diary and pain scales. Subjects will record their pain every morning and every evening for the first 72 hours after surgery. Subjects will complete a satisfaction survey at their 2 week postoperative visit. Adverse postoperative outcomes will be collected for 30 days after surgery.
The study is powered to detect a 20 mm difference in a 100 mm visual analog scale for pain.
- Conditions
- Postoperative Pain
- Being tested
- Liposomal bupivacaine, Placebo - injection
- Keywords
- liposomal bupivacaine, posterior repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called EXPAREL 266 mg
Extended-release local anesthetic
Placebo - injectionDrug
Injectable normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Receives: Drug: Liposomal bupivacaine |
| Placebo | Placebo comparator | Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Receives: Drug: Placebo - injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).
Measured: Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening
Secondary outcomes (9)
Number of Participants Reporting Satisfaction With Pain Control
As measured by a 5-question satisfaction survey administered at a 2 week postoperative visit. The survey includes Likert scale responses ranging from very unsatisfied to very satisfied with the surgical experience and specifically analgesia. "Patient Satisfaction" was defined as response "satisfied" or "very satisfied" on the Likert Scale. Average responses will be reported.
Measured: 2 weeks after surgery
Time to First Opioid Administration
Median time until first opioid administered after surgery
Measured: Assessed up to 72 hours after surgery
Total Opioid Administration
Measured in milligram morphine equivalents
Measured: Cumulatively, over a time period of 72 hours after surgery
Number of Antiemetic Doses Required Per Participant While Inpatient
Number of as-needed antiemetic doses patient received while in the hospital after surgery
Measured: Cumulatively, over a time period of 72 hours after surgery
Hospital Length of Stay
Total length of hospital stay measured in hours, including readmissions
Measured: Assessed until 30 days after surgery
Length of Stay in Post-anesthesia Care Unit (PACU)
Total length of stay in PACU measured in minutes
Measured: Assessed up to 72 hours after surgery
Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days
As recorded by patient - patients were asked each postoperative day (i.e. POD#0, POD#1, POD#2, POD#3) if they had a bowel movement that day, yes or no.
Measured: 72 hours after surgery
Voiding Trial Failures
Proportion of patients discharged home with Foley catheters after failed voiding trials in the hospital
Measured: 2 weeks after surgery
Number of Patients With Adverse Events
Total adverse postoperative events
Measured: Assessed until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start23 Jul 2018
- Primary completion12 Mar 2019
- Study completion31 Mar 2019
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Evans, MD, Principal investigator, Women's Center for Pelvic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875664
- Sponsor's protocol ID
- Pro00024327
- Status last verified
- May 2020
- First submitted
- 13 Mar 2019
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03875664
- Acronym / sponsor ID
- Pro00024327
- Conditions
- Postoperative Pain
- Keywords
- liposomal bupivacaine, posterior repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.
Detailed description
Liposomal bupivacaine (EXPAREL; Pacira Pharmaceuticals, San Diego, CA) is an extended release local anesthetic approved by the Food and Drug Administration since 2011 for the treatment of postsurgical pain. It is a multivesicular liposomal delivery system, consisting of a liquid bupivacaine core encapsulated by a phospholipid shell. This delivery technology allows for the slow, sustained release of bupivacaine over at least 72 hours.
Liposomal bupivacaine has been studied extensively in the general surgery and orthopedic surgery literature. Specifically, infiltration of liposomal bupivacaine after excisional hemorrhoidectomy has been shown to significantly lower postsurgical pain scores, decrease total postoperative opioid requirements, increase the number of patients who do not require any opioids after surgery, meaningfully delay the median time to first opioid use, and improve patient satisfaction with overall perioperative analgesia.
Posterior colporrhaphy and perineorrhaphy are pelvic reconstructive surgical procedures that are associated with significant postsurgical localized pain resulting from surgical incisions. Investigators hypothesize this localized postsurgical pain will benefit from treatment with an extended release local anesthetic formulation similar to hemorrhoidectomy. Intraoperative infiltration of a standard local anesthetic during posterior repair and perineorrhaphy has been shown to improve early analgesia and facilitate early postoperative recovery. These findings reiterate the need for studies investigating a slow-release, longer-acting local anesthetic formulation for patients undergoing posterior repair and/or perineorrhaphy - one that ideally can be integrated into an evidence-based, opioid-sparing postsurgical pain management regimen to improve perioperative care for the steadily growing pelvic reconstructive surgical patient population.
The primary study objective is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS).
Secondary objectives include to evaluate total opioid consumption during the first 72 postoperative hours, to evaluate patient satisfaction with postoperative analgesia, to evaluate time to first opioid administration postoperatively, to evaluate hospital length of stay, to evaluate length of stay in post-anesthesia care unit (PACU), to evaluate total hospital costs, to evaluate time to first bowel movement postoperatively, to evaluate rate of postoperative nausea and vomiting, to evaluate time to successful voiding trial, and to evaluate proportion of patients discharged home with a Foley catheter.
Patients will be approached for participation preoperatively and randomized in the operating room to either liposomal bupivacaine or injectable normal saline administered into the posterior vaginal compartment in a standardized technique. All concurrent minimally invasive pelvic reconstructive surgical procedures are allowed. Randomization will be stratified for abdominal versus purely vaginal surgery. Perioperative care is standardized. Data will be abstracted from the medical record. Additionally, subjects will be discharged home with a medication diary and pain scales. Subjects will record their pain every morning and every evening for the first 72 hours after surgery. Subjects will complete a satisfaction survey at their 2 week postoperative visit. Adverse postoperative outcomes will be collected for 30 days after surgery.
The study is powered to detect a 20 mm difference in a 100 mm visual analog scale for pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Liposomal bupivacaineReceives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique |
| Placebo | Placebo comparator | Drug: Placebo - injectionReceives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse
Key exclusion criteria (6 listed)
- Planned regional anesthesia
- Allergy or contraindication to bupivacaine
- Allergy or contraindication to opioids
- Allergy or contraindication to non-steroidal medications
- Planned laparotomy
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: EXPAREL 266 mgExtended-release local anesthetic | Drug | Intervention |
| Placebo - injectionInjectable normal saline solution | Drug | Placebo |
Primary outcome
Postoperative Pain
Time frame: Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening
As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).
9 secondary outcomes
Number of Participants Reporting Satisfaction With Pain Control
Time frame: 2 weeks after surgery
Time to First Opioid Administration
Time frame: Assessed up to 72 hours after surgery
Total Opioid Administration
Time frame: Cumulatively, over a time period of 72 hours after surgery
Number of Antiemetic Doses Required Per Participant While Inpatient
Time frame: Cumulatively, over a time period of 72 hours after surgery
Hospital Length of Stay
Time frame: Assessed until 30 days after surgery
Length of Stay in Post-anesthesia Care Unit (PACU)
Time frame: Assessed up to 72 hours after surgery
Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days
Time frame: 72 hours after surgery
Voiding Trial Failures
Time frame: 2 weeks after surgery
Number of Patients With Adverse Events
Time frame: Assessed until 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- 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.
Sarah Evans, MD principal investigator
Women's Center for Pelvic Health
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 Postoperative Pain, run by Wake Forest University Health Sciences 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 6 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 13 Sep 2022. 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 13 May 2020). 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?
Postoperative Pain (time frame: Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening). 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 13 Sep 2022.