Injury of Anterior Cruciate Ligament
Conditions
Keywords
anterior cruciate ligament reconstruction, transplantation allografts, adolescent, nerve block, pain
Brief summary
Anterior cruciate ligament repair using hamstring autograft in children is a painful orthopedic procedure. The current practice to provide analgesia for this procedure include femoral continuous perineural infusion and femoral single shot peripheral nerve block, along with perioperative opioids and NSAIDS both IV and orally. Since the use of opioids can be associated with adverse side effects, which include, but are not limited to nausea, vomiting, constipation, pruritus and respiratory depression, comparing the amount of opioid used with either analgesia delivery method is needed.
Detailed description
The trial design is a prospective, randomized, open-label controlled, study. It is not possible to blind the treatment since a catheter must be left in place for the continuous infusion group. Subjects will be randomized to either the femoral shot/continuous peripheral neural infusion FS-CPNI group or femoral shot/sciatic single shot FS-SS group. After induction of general anesthesia, subjects will receive either a single shot or continuous nerve block. The protocol will not dictate the conduct of the general anesthetic. In the postoperative period, in addition to the standard monitoring in the recovery room, the numerical rating pain scale(NRS) scores of the patient will be recorded. The timing of the first rescue pain medication and total postoperative opioid and other analgesic medication administered during the hospital stay will be recorded. The patients will be followed in the hospital on the day of surgery (DOS) postoperatively until they are discharged home. After discharge the patients will be contacted by phone and/or email postoperatively on a daily basis for 72 hours to collect information regarding their use of pain medications (timing and dose), quality of analgesia based on the NRS pain scale, and incidence of side effects. If patients need to be admitted to the hospital postoperatively, their opioid use, pain scores and complications will be recorded while in the hospital. All the patients will be evaluated in the orthopedic clinic at two weeks, six weeks and six months to assess long term functional outcomes, pain scores and any signs of postoperative neurological deficits.
Interventions
DRUGbupivacaine
Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block
DEVICEcontinuous perineural infusion catheter
Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology (ASA) physical status 1 or 2 * Male or female subjects ages 14 to 18 years old at time of procedure * Patients who undergo an ACL repair using the hamstring autograft at The Children's Hospital of Philadelphia * Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion criteria
* Parents/patients refusal to the placement of a femoral and/or sciatic nerve block * Contraindications to femoral and/or sciatic nerve block: 1. Infection 2. Neurologic deficits, including motor and/or sensory deficit of the femoral and sciatic nerves. * Patients' inability to participate in pain scoring because of developmental delay. * Performance of an all-epiphyseal ACL repair. * Allergy to any of the medications used in the study. * Presence of a coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Pain Medication | 72 hours post-operatively | total postoperative opioid pain medication used during the first 72 hours after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group | 72 hours post-operatively | Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief |
Other
| Measure | Time frame | Description |
|---|---|---|
| Failure of Nerve Block Procedures | 72 hours post-operatively | We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups. |
Countries
United States
Participant flow
Recruitment details
Beginning in June 2014, 49 potentially eligible patients were identified. Of these, 35 patients did not meet inclusion/exclusion criteria including, and 3 patients were unable to be contacted by phone pre-operatively. Of the remaining 11 potential patients, 10 declined study participation and only 1 signed consent to participate.
Pre-assignment details
Only 1 subject signed consent to participate.
Participants by arm
| Arm | Count |
|---|---|
| Males Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block | 0 |
| Females Single Shot Peripheral Nerve Block a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).
bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block | 0 |
| Males Continuous Peripheral Neural Infusion The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | 0 |
| Females Continuous Peripheral Neural Infusion The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.
continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Females Continuous Peripheral Neural Infusion |
|---|---|---|
| Age, Categorical <=18 years | 1 participants | 1 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Gender Female | 1 participants | 1 participants |
| Gender Male | 0 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 participants | 0 participants |
| Race (NIH/OMB) Asian | 0 participants | 0 participants |
| Race (NIH/OMB) Black or African American | 0 participants | 0 participants |
| Race (NIH/OMB) More than one race | 0 participants | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 0 participants |
| Race (NIH/OMB) White | 1 participants | 1 participants |
| Region of Enrollment United States | 1 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 1 |
Outcome results
Primary
Opioid Pain Medication
total postoperative opioid pain medication used during the first 72 hours after the procedure
Time frame: 72 hours post-operatively
Population: Sample size was too small to conduct outcome analysis
Secondary
Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group
Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief
Time frame: 72 hours post-operatively
Population: Sample size was too small to conduct outcome analysis
Other Pre-specified
Failure of Nerve Block Procedures
We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.
Time frame: 72 hours post-operatively
Population: Sample size was too small to conduct outcome analysis