ACL, Anterior Cruciate Ligament Injuries
Conditions
Keywords
ACL, Genicular nerve block, Anterior Cruciate Ligament Injuries, Opioid Consumption
Brief summary
The purpose of this randomized controlled trial is to assess a new analgesia regimen that includes the addition of genicular never blocks to our current standard regimen of peripheral nerve blocks, which includes an adductor canal block (ACB) and interspace between the popliteal artery and capsule of the posterior knee block (IPACK). The main questions it aims to answer are: 1. Does addition of genicular nerve blocks to standard peripheral block regimen significantly reduce the mean opioid consumption by 33% in the first 24 hours? 2. Does genicular nerve blocks reduce NRS pain scores? 3. Does genicular nerve blocks facilitate earlier discharge? 4. Does genicular nerve blocks last longer than 24 hours? 5. Does genicular nerve blocks improve pain management? Eligible patients are those undergoing an anterior cruciate ligament repair at the Hospital for Special Surgery and participants will be randomized to receive the intervention (genicular nerve block) or the standard of care.
Detailed description
Genicular nerve blocks have been shown to provide effective analgesia for chronic osteoarthritis knee pain. There are several publications supporting its use for chronic knee pain but there is a scarcity of literature in its use in the perioperative period. Recently, it has been shown to provide effective analgesia for total knee arthroplasty. This will be a novel application for it to be used for anterior cruciate ligament surgery. There are only a couple of prospective and retrospective studies that showed promising analgesic benefits for anterior cruciate ligament repairs. There are currently no randomized controlled trials published investigating the use of genicular nerve blocks for anterior cruciate ligament surgery. Researching novel innovative motor-sparing and opioid-sparing peripheral nerve blocks for have been the focus of research. Studies have investigated the motor sparing benefits of the adductor canal block, the effective analgesic benefits of the IPACK block, the phrenic sparing benefits of the superior trunk block, and the analgesic benefits of the pericapsular nerve group block and lateral femoral cutaneous nerve. Genicular nerve blocks would be a potential additive block that may further enhance the recovery of patients undergoing knee surgeries, including unicondylar, total knee and anterior cruciate ligament repair patients.
Interventions
DRUGGenicular Nerve Block with bupivacaine and preservative free dexamethasone
A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee. The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius. Bupivacaine - Drug class: Sodium channel blocker Dexamethasone - Drug class: Glucocorticoid
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient, research assistants, and biostatisticians are blinded to whether the patient was randomized to the control or intervention group.
Intervention model description
Double blind randomized control trail
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 80 * English speaking * American Society of Anesthesiologists (ASA) I - III * BMI \< 35 * Scheduled for ambulatory arthroscopic unilateral anterior cruciate ligament repair surgery with bone tendon bone autograft
Exclusion criteria
* History of chronic pain syndromes * Chronic opioid use (daily morphine milligram equivalents \> 30 mg for at least 3 months) * Contraindication to peripheral nerve blocks * Contraindication to neuraxial anesthesia * History of peripheral neuropathy or pre-existing neurological deficits * Psychiatric or cognitive disorder that prohibit patient from following study protocol * Allergy to local anesthetic or study medications * Multi-ligament surgery * History of substance abuse * Infection at the site of injection * diagnoses of Type I or Type II diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Opioid Consumption at 24 Hours | Post-operative care unit (PACU) arrival time to 24 hours | Intravenous and Oral opioid consumption at 24 hours after recovery room entry will be recorded. The average consumption will be reported in morphine milligram equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time) | Opioid consumption up to 168 hours after surgery will be recorded from the medical record and patient reported phone calls Opioid consumption in morphine milligram equivalents will be calculated and reported for each time point. |
| Numeric Rating Scale (NRS) Pain Scores | PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time) | Patient scores at rest and with movement will be recorded. Scale of 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain imaginable". Lower score means less pain, higher score means greater pain. |
| Cumulative Opioid Consumption | sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operatively | Total opioid consumption will be recorded up to 96 hours after surgery. |
| Brief Pain Inventory | Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative | This questionnaire will assess severity of pain, impact of pain on daily function, location of pain, medication intake, and amount of pain relief preoperatively and at 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after surgery. Questions are rated on a scale of 0 to 10, with 0 meaning "no pain/interference" and 10 meaning "pain as bad as you can imagine/completely interferes". |
| Patient Satisfaction With Pain Treatment | From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative | Patient satisfaction will be assessed in the post-operative care unit (PACU), 24 hours, and 48 hours after surgery. Patients reported satisfaction for 3 subcategories: 1) Satisfaction with Pain Management, 2) Satisfaction with Being Informed and Involved with Decision Making, 3) Satisfaction with Care from Healthcare Team. Each subcategory had a scale of 0-10, with 0 being strongly dissatisfied and 10 being strongly satisfied. |
| Duration of Analgesic Block | 24 hours and 48 hours post-operative | To assess when the patient believe the analgesic block wore off and they regain sensation in their leg. |
| Success of Adductor Canal Block | Post-operative care unit (PACU) | Numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant. This was measured on scale of 0-2, with 0 being no sensation, 1 being partial sensation, and 2 being full sensation. |
| Readiness for PACU Discharge | From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time the patient is discharged(discharge ready time = recovery complete time) assessed up to 24 hours after surgery. | The duration from PACU arrival time to recovery complete time. The time that it took for the patient to be discharged will be calculated and reported. |
| Length of PACU Stay | From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time they leave the PACU assessed up to 24 hours after surgery. | The duration from PACU arrival time to patient removed from board time. The time (in minutes) will be calculated and reported. |
| Adverse Events | Post-operative care unit (PACU) arrival time up to 72 hours after the surgery | Incidence of neuropraxia (neurological symptoms over 3 days), local anesthetic systemic toxicity (LAST), and infection. The number of adverse events will be reported. |
Countries
United States
Contacts
STUDY_DIRECTORJashvant Poeran, MD/PhD
Hospital for Special Surgery, Department of Anesthesiology
PRINCIPAL_INVESTIGATORDavid H Kim, MD
Hospital for Special Surgery, Department of Anesthesiology
Participant flow
Recruitment details
Enrollment occurred between January 12, 2023 and November 25, 2024 in the preoperative holding area of the Hospital for Special Surgery West Side Ambulatory Surgery Center.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 26.48 years |
| Body Mass Index | 23.95 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
None listed