Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05900427
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-05-22
Brief Title:
Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
Sponsor:
Johnny K Lee
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine PoPTSAWoW Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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 purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores VAS pain scores quality of recovery and opioid use in milligram equivalents at 24 48 72 96 and 120 hours postoperatively in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine
This is a prospective randomized double-blinded controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty Participants who meet all eligibility criteria will be randomized in a 11 ratio to receive either 36 mL of 05 bupivacaine PB group or 10 mL of liposomal bupivacaine and 20 mL of 025 bupivacaine and 6 mL of saline LB group
This is a prospective randomized double-blinded controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty Participants who meet all eligibility criteria will be randomized in a 11 ratio to receive either 36 mL of 05 bupivacaine PB group or 10 mL of liposomal bupivacaine and 20 mL of 025 bupivacaine and 6 mL of saline LB group
Detailed Description:
Patients undergoing shoulder surgery can suffer from significant postoperative pain which can lead to an increase in recovery time opioid use and potential dependency and a decrease in quality of recovery The interscalene brachial plexus block is a common effective regional anesthesia technique used for a variety of procedures involving the shoulder The number of total shoulder arthroplasty surgeries being performed annually in the United States are increasing every year Liposomal bupivacaine was FDA approved for use in patients undergoing interscalene block in 2018 to reduce postoperative pain from shoulder surgery The information from the manufacturer indicates that the liposomal encapsulation may release the drug for up to approximately 72 hours after it has been administered providing a prolonged analgesic effect Evidence to the prolonged analgesic effect of liposomal bupivacaine has varied in the current literature A recent meta-analysis suggested that liposomal bupivacaine may provide a statistically significant but clinically insignificant decrease in opioid consumption and pain scores over time The authors noted a possible limitation of their study is that the meta-analysis included a variety of surgical procedures and block techniques and was not specific to shoulder surgery or interscalene block The authors noted that this variability in anesthetic regimens between study groups could have affected the observed outcomes
Recently the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021 The investigators compared the difference in the proportion of patients with clinically tolerable pain scores defined as VAS 4 in those patients receiving liposomal bupivacaine vs those receiving another local anesthetic plain bupivacaine mepivacaine or ropivacaine vs those receiving no block The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents MMEs
Based on the investigators retrospective results the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs plain bupivacaine only in near equipotent doses The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids This could reduce or inevitably eliminate the unwanted effects of opioids nausea vomiting constipation urinary retention opioid induced respiratory depression dependency and addiction and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties
Recently the investigators performed a retrospective quality improvement study to investigate the potential benefit of liposomal bupivacaine used for interscalene blocks among 491 patients undergoing shoulder arthroplasty between 2018 and 2021 The investigators compared the difference in the proportion of patients with clinically tolerable pain scores defined as VAS 4 in those patients receiving liposomal bupivacaine vs those receiving another local anesthetic plain bupivacaine mepivacaine or ropivacaine vs those receiving no block The results of this study suggested there was significant difference in the proportion of patients with clinically tolerable pain scores when receiving liposomal bupivacaine during all observations and at 3 days postoperatively versus those patient that did not The patients who received liposomal bupivacaine also had a significant reduction in morphine milligram equivalents MMEs
Based on the investigators retrospective results the investigators performed a power analysis which allowed for the development of this prospective randomized double blinded trial comparing liposomal bupivacaine plus plain bupivacaine vs plain bupivacaine only in near equipotent doses The investigators believe that this is a very important and unique trial to perform as it could change the way pain management is delivered in this patient population Longer acting local anesthetic used for interscalene blocks may increase the number of patients who have tolerable pain and require less or no opioids This could reduce or inevitably eliminate the unwanted effects of opioids nausea vomiting constipation urinary retention opioid induced respiratory depression dependency and addiction and result in an improvement in the quality of recovery of patients undergoing total shoulder arthroplasties
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None