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

Primary Purpose

Injury of Anterior Cruciate Ligament

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bupivacaine
bupivacaine
continuous perineural infusion catheter
continuous perineural infusion catheter
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injury of Anterior Cruciate Ligament focused on measuring anterior cruciate ligament reconstruction, transplantation allografts, adolescent, nerve block, pain

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital Of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Males Single shot peripheral nerve block

Females Single shot peripheral nerve block

Males Continuous peripheral neural infusion

Females Continuous peripheral neural infusion

Arm Description

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).

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).

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.

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.

Outcomes

Primary Outcome Measures

Opioid Pain Medication
total postoperative opioid pain medication used during the first 72 hours after the procedure

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2014
Last Updated
April 13, 2016
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02075411
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficult to enroll, parents/subjects prefer to choose type of anesthetic block.
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Anterior Cruciate Ligament
Keywords
anterior cruciate ligament reconstruction, transplantation allografts, adolescent, nerve block, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Males Single shot peripheral nerve block
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Females Single shot peripheral nerve block
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Males Continuous peripheral neural infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Females Continuous peripheral neural infusion
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
sciatic nerve block, ACL repair
Intervention Description
Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Other Intervention Name(s)
sciatic nerve block, ACL repair
Intervention Description
Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block
Intervention Type
Device
Intervention Name(s)
continuous perineural infusion catheter
Other Intervention Name(s)
continuous peripheral nerve catheter infusion, pain control, ACL repair
Intervention Description
Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Intervention Type
Device
Intervention Name(s)
continuous perineural infusion catheter
Other Intervention Name(s)
continuous peripheral nerve catheter infusion, pain control, ACL repair
Intervention Description
Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Primary Outcome Measure Information:
Title
Opioid Pain Medication
Description
total postoperative opioid pain medication used during the first 72 hours after the procedure
Time Frame
72 hours post-operatively
Secondary Outcome Measure Information:
Title
Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group
Description
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
Other Pre-specified Outcome Measures:
Title
Failure of Nerve Block Procedures
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Infection 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harshad Gurnaney, MBBS, MPH
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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