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

NCT02075411 | Terminated Phase 3 Results DMC

• 1 other identifier: 12-009320
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury of Anterior Cruciate Ligament

Keywords

anterior cruciate ligament reconstruction; transplantation allografts; adolescent; nerve block; pain

Outcome Measures

Primary Outcomes (1)

• Opioid Pain Medication

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

  72 hours post-operatively

Secondary Outcomes (1)

• Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group

  72 hours post-operatively

Other Outcomes (1)

• Failure of Nerve Block Procedures

  72 hours post-operatively

Study Arms (4)

Males Single shot peripheral nerve block

ACTIVE COMPARATOR

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

Females Single shot peripheral nerve block

ACTIVE COMPARATOR

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

Males Continuous peripheral neural infusion

ACTIVE COMPARATOR

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

Females Continuous peripheral neural infusion

ACTIVE COMPARATOR

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

Interventions

bupivacaine DRUG

Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block

Also known as: sciatic nerve block, ACL repair

Males Single shot peripheral nerve block

continuous perineural infusion catheter DEVICE

Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.

Also known as: continuous peripheral nerve catheter infusion, pain control, ACL repair

Males Continuous peripheral neural infusion

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain

Interventions

Bupivacaine; Analgesia

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia

Limitations and Caveats

Due limited enrollment and early termination of this study, analysis of outcome data was not possible.

Results Point of Contact

• Title: Harshad Gurnaney, MBBS, MPH
• Organization: Children's Hospital of Philadelphia

gurnaney@email.chop.edu

215-590-1858

Study Officials

• Harshad Gurnaney, MBBS, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 18, 2016
• Results First Posted: May 18, 2016

Record last verified: 2016-04

Locations

US (1)