Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559215
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament MPFL reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use The main questions it aims to answer are
Does Exparel significantly reduce Visual Analog Scale VAS pain scores and pain levels up to one week postoperatively
Does Exparel significantly decrease narcotic use number of pills taken up to one week postoperatively
Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively
Participants will
receive either Exparel Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery
receive and complete questionnaires at postoperative days 1 4 and 7 regarding their pain scores levels and outcomes effective pain treatments overall pain interference narcotic use number of pills taken and overall pain treatment satisfaction
receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
Does Exparel significantly reduce Visual Analog Scale VAS pain scores and pain levels up to one week postoperatively
Does Exparel significantly decrease narcotic use number of pills taken up to one week postoperatively
Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively
Participants will
receive either Exparel Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery
receive and complete questionnaires at postoperative days 1 4 and 7 regarding their pain scores levels and outcomes effective pain treatments overall pain interference narcotic use number of pills taken and overall pain treatment satisfaction
receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1
Detailed Description:
This is a single institution prospective single-blinded participant randomized controlled trial to investigate the pain-control efficacy and patient reported pain outcomes of Exparel use in youth receiving medial patellofemoral ligament MPFL Reconstruction Participants will be approached pre-operatively for participation after which the surgical team will be informed Participants will be offered the choice to participate in the study and randomize their treatment group If participants do not want their treatment to be randomized they will not be included in the study
Participants enrolled in this study will receive either Exparel Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery At post-operative days 1 4 and 7 participants will receive and complete questionnaires regarding their pain scores levels and outcomes effective pain treatments overall pain interference narcotic use number of pills taken and overall pain treatment satisfaction Additionally participants may receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery
As per the institutional pain management protocol participants will receive the following anesthesia doses by body weight BW
Pre-operatively
Regardless of age 05 mg midazolam per kg BW intravenous 15 mg maximum
If patient has history of post-operative nausea or vomiting PONV 040 mg Emend per kg BW pill and 2 mg midazolam intravenous
Intra-operatively
05-10 mg Lidocaine per kg BW intravenous 80 mg maximum
3-4 mg Propofol per kg BW
1-2 mcg Fentanyl per kg BW maximum 100 mcg
035 mg Ketamine per kg BW single dose or titration
01 mg Dexamethasone per kg BW maximum 10 mg
Optional
10-20 mcg Dexmedetomidine per kg BW for persistent tachycardia
If intubatedventilated 05-06 mg Rocuronium per kg BW 2 mgkg sugammadex for reversal
If Tranexamic Acid administered 15 mg per kg BW 10-15 min intravenous maximum 1 g
For maintenance 1 Minimum Alveolar Concentration MAC Sevoflurane and 15 mg Acetaminophen per kg BW maximum 1 g
If necessary during emergence 0004-0005 mg hydromorphone per kg BW 05 mg Ketorolac per kg BW maximum 30 mg and 01 mg Ondansetron per kg BW maximum 4 mg
If post-anesthesia care unit PACU Phase 1 medication required 0004-0006 mg hydromorphone per kg BW and 010-015 mg Oxycodone per kg BW
If PACU Phase 2 medication required Metoclopramide Dexamethasone Promethazine or Ondansetron
Post-Operatively
If 12 years
Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
Rescue Weight-adjusted AcetaminophenHydrocodone substituted for Acetaminophen for severe pain every 6 hours maximum 8 doses
If 12 years
Days 1-3 Alternate weight-adjusted Acetaminophen and 10 mg Ketorolac every 3 hours
Days 4-7 Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
Days 1-5 40 mg Famotidine every 12 hours
Rescue Weight-adjusted Tramadol taken with Acetaminophen for severe pain every 6 hours maximum 8 doses
The investigators will enroll 50 participants in each treatment group with 40 in each group needed for a sufficiently powered analysis
Participants enrolled in this study will receive either Exparel Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery At post-operative days 1 4 and 7 participants will receive and complete questionnaires regarding their pain scores levels and outcomes effective pain treatments overall pain interference narcotic use number of pills taken and overall pain treatment satisfaction Additionally participants may receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery
As per the institutional pain management protocol participants will receive the following anesthesia doses by body weight BW
Pre-operatively
Regardless of age 05 mg midazolam per kg BW intravenous 15 mg maximum
If patient has history of post-operative nausea or vomiting PONV 040 mg Emend per kg BW pill and 2 mg midazolam intravenous
Intra-operatively
05-10 mg Lidocaine per kg BW intravenous 80 mg maximum
3-4 mg Propofol per kg BW
1-2 mcg Fentanyl per kg BW maximum 100 mcg
035 mg Ketamine per kg BW single dose or titration
01 mg Dexamethasone per kg BW maximum 10 mg
Optional
10-20 mcg Dexmedetomidine per kg BW for persistent tachycardia
If intubatedventilated 05-06 mg Rocuronium per kg BW 2 mgkg sugammadex for reversal
If Tranexamic Acid administered 15 mg per kg BW 10-15 min intravenous maximum 1 g
For maintenance 1 Minimum Alveolar Concentration MAC Sevoflurane and 15 mg Acetaminophen per kg BW maximum 1 g
If necessary during emergence 0004-0005 mg hydromorphone per kg BW 05 mg Ketorolac per kg BW maximum 30 mg and 01 mg Ondansetron per kg BW maximum 4 mg
If post-anesthesia care unit PACU Phase 1 medication required 0004-0006 mg hydromorphone per kg BW and 010-015 mg Oxycodone per kg BW
If PACU Phase 2 medication required Metoclopramide Dexamethasone Promethazine or Ondansetron
Post-Operatively
If 12 years
Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
Rescue Weight-adjusted AcetaminophenHydrocodone substituted for Acetaminophen for severe pain every 6 hours maximum 8 doses
If 12 years
Days 1-3 Alternate weight-adjusted Acetaminophen and 10 mg Ketorolac every 3 hours
Days 4-7 Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
Days 1-5 40 mg Famotidine every 12 hours
Rescue Weight-adjusted Tramadol taken with Acetaminophen for severe pain every 6 hours maximum 8 doses
The investigators will enroll 50 participants in each treatment group with 40 in each group needed for a sufficiently powered analysis
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