Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590402
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 pilot clinical trial is to compare anterior femoral cutaneous nerve block AFCN to adductor canal block ACB for pediatric patients undergoing either anterior cruciate ligament ACL or medial patellofemoral ligament MPFL The aims of this trial are
To measure postoperative functional outcomes in patients who received AFCNB vs ACB
To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs ACB
To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs ACB
To quantify sensory deficits in patients who received AFCNB vs ACB
Subjects undergoing ACL procedures will be compared between those who received the adductor canal block to those who received the anterior femoral cutaneous nerve block The researchers will also compare individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block with those who received the adductor canal block
Participants will
Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia
Maintain a patient diary to document daily pain medspain scores
Complete follow up surveysquestionnaires via telephone and during their office visits with surgeons
To measure postoperative functional outcomes in patients who received AFCNB vs ACB
To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs ACB
To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs ACB
To quantify sensory deficits in patients who received AFCNB vs ACB
Subjects undergoing ACL procedures will be compared between those who received the adductor canal block to those who received the anterior femoral cutaneous nerve block The researchers will also compare individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block with those who received the adductor canal block
Participants will
Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia
Maintain a patient diary to document daily pain medspain scores
Complete follow up surveysquestionnaires via telephone and during their office visits with surgeons
Detailed Description:
There is scant literature on the efficacy of peripheral nerve blocks or the comparative effectiveness of anesthesia and analgesia techniques in pediatricadolescent patients undergoing orthopedic procedures particularly ambulatory knee procedures such as anterior cruciate ligament ACL reconstruction and medial patellofemoral ligament MPFL reconstruction Given the innervation to the knee and concern with residual functional impairment the goal of our pilot study is to collect preliminary information comparing the anterior femoral cutaneous nerve block AFCNB vs adductor canal block ACB in the hopes of using this data to power a larger randomized controlled trial to rigorously study this clinical question
This pilot clinical trial aims to find out what the differences are between anterior femoral cutaneous nerve block AFCN and adductor canal block ACB for pediatric patients who are having either anterior cruciate ligament ACL or medial patellofemoral ligament MPFL surgery There will be 30 subjects in each grouptype of surgery The aims of this trial are
To measure postoperative functional outcomes in patients who received AFCNB vs ACB
To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs ACB
To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs ACB
To quantify sensory deficits in patients who received AFCNB vs ACB
30 Subjects undergoing ACL procedures will be compared between those who received the adductor canal block 15 to those who received the anterior femoral cutaneous nerve block 15 The researchers will also compare 30 individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block 15 with those who received the adductor canal block 15
Eligible and enrolled participants will
Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia
Maintain a patient diary to document daily pain medspain scores
Complete follow up surveysquestionnaires via telephone and during their office visits with surgeons
This pilot clinical trial aims to find out what the differences are between anterior femoral cutaneous nerve block AFCN and adductor canal block ACB for pediatric patients who are having either anterior cruciate ligament ACL or medial patellofemoral ligament MPFL surgery There will be 30 subjects in each grouptype of surgery The aims of this trial are
To measure postoperative functional outcomes in patients who received AFCNB vs ACB
To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs ACB
To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs ACB
To quantify sensory deficits in patients who received AFCNB vs ACB
30 Subjects undergoing ACL procedures will be compared between those who received the adductor canal block 15 to those who received the anterior femoral cutaneous nerve block 15 The researchers will also compare 30 individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block 15 with those who received the adductor canal block 15
Eligible and enrolled participants will
Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia
Maintain a patient diary to document daily pain medspain scores
Complete follow up surveysquestionnaires via telephone and during their office visits with surgeons
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