Clinical trial NCT03875664: Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
Official title: Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: liposomal bupivacaine
posterior repair
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 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:
measure: Number of Participants Reporting Satisfaction With Pain Control
timeFrame: 2 weeks after surgery
measure: Time to First Opioid Administration
timeFrame: Assessed up to 72 hours after surgery
measure: Total Opioid Administration
timeFrame: Cumulatively, over a time period of 72 hours after surgery
measure: Number of Antiemetic Doses Required Per Participant While Inpatient
timeFrame: Cumulatively, over a time period of 72 hours after surgery
measure: Hospital Length of Stay
timeFrame: Assessed until 30 days after surgery
measure: Length of Stay in Post-anesthesia Care Unit (PACU)
timeFrame: Assessed up to 72 hours after surgery
measure: Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days
timeFrame: 72 hours after surgery
measure: Voiding Trial Failures
timeFrame: 2 weeks after surgery
measure: Number of Patients With Adverse Events
timeFrame: Assessed until 30 days after surgery
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Women's Center for Pelvic Health
state: North Carolina
Study officials:
affiliation: Women's Center for Pelvic Health
name: Sarah Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: