Anterior Cruciate Ligament Reconstruction, Medial Patellofemoral Ligament Reconstruction
Conditions
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. * 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.
Detailed description
There is scant literature on the efficacy of peripheral nerve blocks or the comparative effectiveness of anesthesia and analgesia techniques in pediatric/adolescent 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 group/type 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. * 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. 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 meds/pain scores * Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.
Interventions
DRUGBupivacaine, Dexamethasone in Adductor Canal Block
0.25% 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
DRUGBupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
10 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
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of the patient/parent or guardian and research staff collecting data will be maintained via the SNOSE technique (Sequentially Numbered Opaque Sealed Envelope), whereby prior to study start, a research staff member not otherwise involved in the study will prepare envelopes with the randomization written on the card and secured in the envelopes, and the study ID number written outside the envelope.
Intervention model description
A double-blinded pilot parallel group-randomized trial (GRT), subjects are enrolled and randomized based on their condition, and there is no cross-over of the groups
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 8-18 years old at the time of surgery * Patients 40kg and above * ACL reconstruction of MPFL reconstruction surgery with participating surgeons
Exclusion criteria
* revision surgery * bilateral surgery * general anesthesia * contraindications to any part of the study protocol * relevant pre-existing neurological deficit * chronic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Function (Motor strength in quadriceps) | 3 months | Collected at standard of care postoperative clinical visits with surgeon. Quadriceps strength is measured bilaterally by a handheld dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption (MMEs) | at postoperative day 7 & 14 | 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 |
| Opioid consumption | at 6 weeks, 3 months, 6 months | defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively |
| Pain Numerical Rating Scale (NRS) at rest | 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 postoperatively | Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable. |
| Pain Numerical Rating Scale (NRS) with ambulation | preop (baseline); in PACU; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperatively | Defined on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. |
| Postoperative pain location(s) | at 2 weeks, 6 weeks, 3 months, 6 months | Collected at standard of care postoperative clinical visits (2 weeks, 6 weeks, 3 months, 6 months). Will be collected on a knee dermatomal map (with incisions depicted) with location(s) of pain marked and average pain scores at each location |
| Cumulative opioid consumption (MMEs) | 48 hours after surgery | 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) |
| Satisfaction with pain management | at postoperative days 1, 2, 7, and 14 | measured on a scale from 0 to 10, where 0 is very dissatisfied and 10 is very satisfied with the pain management regimen. |
| postoperative sensation | at 2 weeks, 6 weeks, 3 months, and 6 months | collected at standard of care postoperative clinical visits (2 weeks, 6 weeks, 6 months). Will be measured on a knee dermatomal map (with incisions depicted) and classified as normal, decreased, or paresthesia when compared to the contralateral knee. |
| postoperative function - motor strength in quadriceps | at 2 weeks, 6 weeks, 6 months | collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer |
| postoperative function - range of motion (ROM) | at 2 weeks, 6 weeks, 3 months, 6 months | collected at standard of care postoperative clinical visits with surgeon; range of motion (ROM): measured bilaterally by goniometer |
| postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function. | at 2 weeks, 6 weeks, 3 months, 6 months | collected at standard of care postoperative clinical visits with surgeon; physical function: PROMIS. If the patient is less than 18 years of age, will be assessed using the PROMIS Pediatric Short Form v1.0 - Physical Activity, which contains questions regarding performance of activities such as exercise and play in the past 7 days with 5 answer choices: no days, 1 day, 2-3 days, 4-5 days, and 6-7 days. If the patient is 18 years of age, will be assessed using the PROMIS Scale v1.2 - Global Health, which contains questions regarding physical and mental health rated 1-5, where 1 is worst and 5 is best (physical raw, T, and health scores will be calculated). |
| Pain expectation scale | at postoperative days 1, 2, 7, and 14 | patient reported on a scale of less, same, or more \[or unknown\] than expected. With less being the lower score and more being the higher score. |
Countries
United States
Contacts
Primary ContactMarko Popovic
Backup ContactAlex Sideris, PhD
Outcome results
None listed