Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 14 - 18 |
| Updated: | 2/7/2015 |
| Start Date: | March 2014 |
| End Date: | August 2016 |
| Contact: | Harshad Gurnaney, MBBS, MPH |
| Email: | gurnaney@email.chop.edu |
| Phone: | 215-590-1858 |
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.
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.
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.
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.
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.
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
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