Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair

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.

Study Overview

• Status: Terminated
• Conditions: Injury of Anterior Cruciate Ligament
• Intervention / Treatment: Drug: bupivacaine; Drug: bupivacaine; Device: continuous perineural infusion catheter; Device: continuous perineural infusion catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: bupivacaine; Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block; Other Names: sciatic nerve block; ACL repair; Drug: bupivacaine; Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block; Other Names: sciatic nerve block; ACL repair
Active Comparator: 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).	Drug: bupivacaine; Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block; Other Names: sciatic nerve block; ACL repair; Drug: bupivacaine; Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block; Other Names: sciatic nerve block; ACL repair
Active Comparator: 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.	Device: continuous perineural infusion catheter; Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.; Other Names: ACL repair; continuous peripheral nerve catheter infusion; pain control; Device: continuous perineural infusion catheter; Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.; Other Names: ACL repair; continuous peripheral nerve catheter infusion; pain control
Active Comparator: 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.	Device: continuous perineural infusion catheter; Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.; Other Names: ACL repair; continuous peripheral nerve catheter infusion; pain control; Device: continuous perineural infusion catheter; Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.; Other Names: ACL repair; continuous peripheral nerve catheter infusion; pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Pain Medication	total postoperative opioid pain medication used during the first 72 hours after the procedure	72 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	72 hours post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours post-operatively

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Harshad Gurnaney, MBBS, MPH, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 28, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: pain; adolescent; nerve block; anterior cruciate ligament reconstruction; transplantation allografts
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 12-009320