Clinical trial NCT02075411: Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair
Official title: A Randomized, Controlled Trial to Evaluate Opioid Usage Associated With Femoral Continuous Perineural Infusion and Femoral Single Shot Peripheral Nerve Block After a Hamstring Autograft Anterior Cruciate Ligament Repair.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Injury of Anterior Cruciate Ligament
Keywords: anterior cruciate ligament reconstruction
transplantation allografts
adolescent
nerve block
pain
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 1
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Pain Medication
timeFrame: 72 hours post-operatively
Secondary outcomes:
measure: Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group
timeFrame: 72 hours post-operatively
Other outcomes:
measure: Failure of Nerve Block Procedures
timeFrame: 72 hours post-operatively
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital Of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Harshad Gurnaney, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: