Injury of Anterior Cruciate LigamentPhase 3NCT02075411
Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair
A Phase 3 study testing bupivacaine and continuous perineural infusion catheter in people with Injury of Anterior Cruciate Ligament, run by Children's Hospital of Philadelphia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Injury of Anterior Cruciate Ligament
- What is being tested?
- bupivacaine and continuous perineural infusion catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
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.
Read the 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
- Being tested
- bupivacaine, continuous perineural infusion catheter
- Keywords
- anterior cruciate ligament reconstruction, transplantation allografts, adolescent, nerve block, pain
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
Also called sciatic nerve block, ACL repair
Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Males Single shot peripheral nerve block
bupivacaineDrug
Also called sciatic nerve block, ACL repair
Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
Females Single shot peripheral nerve block
continuous perineural infusion catheterDevice
Also called continuous peripheral nerve catheter infusion, pain control, ACL repair
Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
continuous perineural infusion catheterDevice
Also called continuous peripheral nerve catheter infusion, pain control, ACL repair
Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: 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. Receives: Device: continuous perineural infusion catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Pain Medication
total postoperative opioid pain medication used during the first 72 hours after the procedure
Measured: 72 hours post-operatively
Secondary outcomes (1)
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
Measured: 72 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Difficult to enroll, parents/subjects prefer to choose type of anesthetic block.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injury of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harshad Gurnaney, MBBS, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075411
- Sponsor's protocol ID
- 12-009320
- Status last verified
- Apr 2016
- First submitted
- 25 Feb 2014
- Last updated
- 18 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02075411
- Acronym / sponsor ID
- 12-009320
- Conditions
- Injury of Anterior Cruciate Ligament
- Keywords
- anterior cruciate ligament reconstruction, transplantation allografts, adolescent, nerve block, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to enroll, parents/subjects prefer to choose type of anesthetic block.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Males Single shot peripheral nerve block | Active comparator | Drug: bupivacainea 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). |
| Females Single shot peripheral nerve block | Active comparator | Drug: bupivacainea 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). |
| Males Continuous peripheral neural infusion | Active comparator | Device: continuous perineural infusion catheterThe 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. |
| Females Continuous peripheral neural infusion | Active comparator | Device: continuous perineural infusion catheterThe 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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Parents/patients refusal to the placement of a femoral and/or sciatic nerve block
- Contraindications to femoral and/or sciatic nerve block:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaineAlso: sciatic nerve block, ACL repairAdolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block | Drug | Males Single shot peripheral nerve block |
| bupivacaineAlso: sciatic nerve block, ACL repairAdolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block | Drug | Females Single shot peripheral nerve block |
| continuous perineural infusion catheterAlso: continuous peripheral nerve catheter infusion, pain control, ACL repairAdolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | Device | Males Continuous peripheral neural infusion |
| continuous perineural infusion catheterAlso: continuous peripheral nerve catheter infusion, pain control, ACL repairAdolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | Device | Females Continuous peripheral neural infusion |
Primary outcome
Opioid Pain Medication
Time frame: 72 hours post-operatively
total postoperative opioid pain medication used during the first 72 hours after the procedure
1 secondary outcome
Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group
Time frame: 72 hours post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harshad Gurnaney, MBBS, MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bupivacaine and continuous perineural infusion catheter in people with Injury of Anterior Cruciate Ligament, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Pain Medication (time frame: 72 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.