Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age8-18
SponsorHospital for Special Surgery, New York
About this trial
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. * To assess patient-reported outcome measures (e.g., pain expectation scale, pain management satisfaction, PROMIS Pediatric Short Form v1.0 - Physical Activity, PROMIS Scale v1.2 - Global Health) in patients 8-18 years of age 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 meds/pain scores * Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
8-18 years old at the time of surgery
Patients 40kg and above
ACL reconstruction of MPFL reconstruction surgery with participating surgeons
Disqualifiers
revision surgery
bilateral surgery
general anesthesia
contraindications to any part of the study protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine, Dexamethasone in Adductor Canal Block
Drug0.25% 15-20ml bupivacaine (local anesthestic) delivered as part of the adductor canal block with 2 mg preservative-free dexamethasone (corticosteroid) delivered as part of the adductor canal block
Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Drug10 ml of 0.25% bupivacaine (local anesthetic) delivered as part of the anterior femoral cutaneous nerve block with 2 mg preservative-free dexamethasone (corticosteroid) delivered as part of the anterior femoral cutaneous nerve block
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Anterior Cruciate Ligament (ACL) surgeriesExperimental treatment 2 interventions
Group B: Medial Patellofemoral Ligament (MPFL) surgeriesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Postoperative Function (Motor strength in quadriceps)
Collected at standard of care postoperative clinical visits with surgeon. Quadriceps strength is measured bilaterally by a handheld dynamometer.
Time frame
3 monthsSecondary outcomes
1
Cumulative opioid consumption (MMEs)
Opioids administered to or consumed by patient in the first 48 hours after surgery (starting from "PACU in" time to 48 hours after "PACU in" time)
Time frame
48 hours after surgery2
Total opioid consumption (MMEs)
defined as cumulative opioid consumption (in MME) from PACU transfer in time to 7 days postoperatively and from PACU transfer in time to 14 days postoperatively
Time frame
at postoperative day 7 & 143
Opioid consumption
defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively
Time frame
at 6 weeks, 3 months, 6 months4
Pain Numerical Rating Scale (NRS) at rest
Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame
preop (baseline); every 30 minutes beginning from PACU transfer in time to discharge; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov