Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2019 |
| Start Date: | July 23, 2018 |
| End Date: | March 27, 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
