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

Injury of Anterior Cruciate Ligament Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02075411
• Other study ID #: 12-009320
• Status: Terminated
• Phase: Phase 3
• First received: February 25, 2014
• Last updated: February 3, 2015
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Injury of Anterior Cruciate Ligament

Intervention

Drug:
• bupivacaine
Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block
• bupivacaine
Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block

Device:
• continuous perineural infusion catheter
Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
• continuous perineural infusion catheter
Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.

Locations

Country	Name	City	State
United States	The Children's Hospital Of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 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	No
Primary	opioid pain medication	total postoperative opioid pain medication used during the first 72 hours after the procedure	72 hours post-operatively	No
Secondary	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	No