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

NCT ID: NCT02075411

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-02-28

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.

Conditions

Injury of Anterior Cruciate Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

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

Males Single shot peripheral nerve block

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).

Group Type: ACTIVE_COMPARATOR

bupivacaine

Intervention Type: DRUG

Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.

Females Single shot peripheral nerve block

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.

Group Type: ACTIVE_COMPARATOR

continuous perineural infusion catheter

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

continuous perineural infusion catheter

Intervention Type: DEVICE

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

Interventions

bupivacaine

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

Males Single shot peripheral nerve block

Intervention Type: DRUG

bupivacaine

Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.

Females Single shot peripheral nerve block

Intervention Type: DRUG

continuous perineural infusion catheter

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

Intervention Type: DEVICE

continuous perineural infusion catheter

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

Intervention Type: DEVICE

Other Intervention Names

sciatic nerve block; ACL repair; sciatic nerve block; ACL repair; continuous peripheral nerve catheter infusion; pain control; ACL repair; continuous peripheral nerve catheter infusion; pain control; ACL repair

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:

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harshad Gurnaney, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital Of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

12-009320

Identifier Type: -

Identifier Source: org_study_id