Trial record 5 of 55 for:    Open Studies | "Anterior Cruciate Ligament"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT02075411
First received: February 25, 2014
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Injury of Anterior Cruciate Ligament
Drug: bupivacaine
Device: continuous perineural infusion catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • opioid pain medication [ Time Frame: 72 hours post-operatively ] [ Designated as safety issue: No ]
    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 [ Time Frame: 72 hours post-operatively ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Failure of nerve block procedures [ Time Frame: 72 hours post-operatively ] [ Designated as safety issue: No ]
    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 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.


Estimated Enrollment: 48
Study Start Date: March 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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:
  • continuous peripheral nerve catheter infusion
  • pain control
  • ACL repair
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 females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
Other Names:
  • continuous peripheral nerve catheter infusion
  • pain control
  • ACL repair

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

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02075411

Contacts
Contact: Harshad Gurnaney, MBBS, MPH 215-590-1858 gurnaney@email.chop.edu
Contact: Theodora K. Goebel, RN,BSN,CCRC 215-590-4925 goebelt@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital Of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Harshad Gurnaney, MBBS, MPH    215-590-1858    gurnaney@email.chop.edu   
Contact: Theodora K. Goebel, RN,BSN,CCRC    215-590-4925    goebelt@email.chop.edu   
Principal Investigator: Harshad Gurnaney, MBBS, MPH         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Harshad Gurnaney, MBBS, MPH Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02075411     History of Changes
Other Study ID Numbers: 12-009320
Study First Received: February 25, 2014
Last Updated: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
anterior cruciate ligament reconstruction
transplantation allografts
adolescent
nerve block
pain

Additional relevant MeSH terms:
Wounds and Injuries
Bupivacaine
Analgesics, Opioid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics

ClinicalTrials.gov processed this record on July 22, 2014