Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02352922
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2015-01-27
Brief Title:
Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy
Sponsor:
AdventHealth
Organization:
AdventHealth
Study Overview
Official Title:
A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are studying ways to improve pain control after surgery One way to decrease pain is to inject incisions with a numbing medicine local anesthetic while in the operating room There is an FDA approved extended-release version of a commonly used local anesthetic bupivacaine that can last for 4 days instead of 6 hours The investigators are studying whether using the extended-release medication Exparel will give better pain relief after laparoscopic and robotic-assisted hysterectomies
Detailed Description:
Lidocaine and bupivacaine hydrochloride HCl are the most commonly used drugs for wound infiltration during laparoscopic surgery for post-operative pain control There is some evidence that wound infiltration decreases immediate post-operative pain While bupivacaine has a slightly slower onset of action 5-10 minutes it has become the preferred injectable anesthetic for surgical use because of its longer duration of effect 4-8 hours versus 1-2 hours for lidocaine
DepoFoam bupivacaine EXPAREL Pacira Pharmaceuticals Inc Parsippany NJ USA is a newer extended-release formulation of bupivacaine HCl approved by the US Federal Drug Administration in October 2011 In this suspension bupivacaine is encapsulated in microscopic spherical lipid-based particles of varying size to allow dispersion of the drug over an extended period of time Analgesia is prolonged up to 96 hours Given the extended duration of action this liposomal bupivacaine may be better at providing post-operative pain relief in laparoscopic surgery
Phase three trials have shown better pain control in the first 24 hours and less opioid use overall in bunionectomies hemorrhoidectomies and total knee replacement surgery when compared to placebo No studies however have been published evaluating extended-release liposomal bupivacaine for laparoscopic surgery or gynecologic surgery in general Currently we are using liposomal bupivacaine for pain relief after laparoscopic hysterectomies but as stated it has never been formally evaluated
We hypothesize that liposomal bupivacaine extended-release provides extended pain relief and decreases the need for supplemental opioid use after major laparoscopic surgery We will be evaluating whether pre-incision infiltration of extended-release bupivacaine decreases post-operative pain from laparoscopic and robotic-assisted hysterectomy compared to bupivacaine HCl short-acting To achieve this evaluation we designed a double-blinded randomized controlled trial
Patients who are scheduled to undergo a laparoscopic or robotic-assisted hysterectomy will be invited to participate Group A will receive pre-incision infiltration of each trocar site with 4 ml of 025 Bupivacaine HCl Group B will receive pre-incision infiltration of each trocar site with 4 ml of extended-release bupivacaine EXPAREL 133mgml Subjects and outcome assessors will be blinded to group allocation
Data will be collected while patients are in the hospital on pain levels and consumption of opioid pain medications Upon discharge pain levels functioning and quantity of opioid and non-steroidal anti-inflammatory NSAID pain medications will be collected through online questionnaires Subjects will be followed until their 2-3 weeks post-operative visit
DepoFoam bupivacaine EXPAREL Pacira Pharmaceuticals Inc Parsippany NJ USA is a newer extended-release formulation of bupivacaine HCl approved by the US Federal Drug Administration in October 2011 In this suspension bupivacaine is encapsulated in microscopic spherical lipid-based particles of varying size to allow dispersion of the drug over an extended period of time Analgesia is prolonged up to 96 hours Given the extended duration of action this liposomal bupivacaine may be better at providing post-operative pain relief in laparoscopic surgery
Phase three trials have shown better pain control in the first 24 hours and less opioid use overall in bunionectomies hemorrhoidectomies and total knee replacement surgery when compared to placebo No studies however have been published evaluating extended-release liposomal bupivacaine for laparoscopic surgery or gynecologic surgery in general Currently we are using liposomal bupivacaine for pain relief after laparoscopic hysterectomies but as stated it has never been formally evaluated
We hypothesize that liposomal bupivacaine extended-release provides extended pain relief and decreases the need for supplemental opioid use after major laparoscopic surgery We will be evaluating whether pre-incision infiltration of extended-release bupivacaine decreases post-operative pain from laparoscopic and robotic-assisted hysterectomy compared to bupivacaine HCl short-acting To achieve this evaluation we designed a double-blinded randomized controlled trial
Patients who are scheduled to undergo a laparoscopic or robotic-assisted hysterectomy will be invited to participate Group A will receive pre-incision infiltration of each trocar site with 4 ml of 025 Bupivacaine HCl Group B will receive pre-incision infiltration of each trocar site with 4 ml of extended-release bupivacaine EXPAREL 133mgml Subjects and outcome assessors will be blinded to group allocation
Data will be collected while patients are in the hospital on pain levels and consumption of opioid pain medications Upon discharge pain levels functioning and quantity of opioid and non-steroidal anti-inflammatory NSAID pain medications will be collected through online questionnaires Subjects will be followed until their 2-3 weeks post-operative visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None