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Difficult to enroll, parents/subjects prefer to choose type of anesthetic block.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine | Drug | Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Pain Medication | total postoperative opioid pain medication used during the first 72 hours after the procedure | 72 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 numerical rating scale (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 |
Inclusion Criteria:
Exclusion Criteria:
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.
Presence of a coagulopathy
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| Name | Affiliation | Role |
|---|---|---|
| Harshad Gurnaney, MBBS, MPH | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Only 1 subject signed consent to participate.
Beginning in June 2014, 49 potentially eligible patients were identified. Of these, 35 patients did not meet inclusion/exclusion criteria including, and 3 patients were unable to be contacted by phone pre-operatively. Of the remaining 11 potential patients, 10 declined study participation and only 1 signed consent to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| bupivacaine | Drug | Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block |
|
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| continuous perineural infusion catheter | Device | Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
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| continuous perineural infusion catheter | Device | Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
|
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| FG001 | 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). bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block |
| FG002 | 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. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| FG003 | 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. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block |
| BG001 | 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). bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block |
| BG002 | 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. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| BG003 | 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. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number | participants |
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| Gender | Number | participants |
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| Race (NIH/OMB) | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Pain Medication | total postoperative opioid pain medication used during the first 72 hours after the procedure | Sample size was too small to conduct outcome analysis | Posted | 72 hours post-operatively |
|
| ||||||||||||||||||||||||||||
| 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 | Sample size was too small to conduct outcome analysis | Posted | 72 hours post-operatively |
| |||||||||||||||||||||||||||||
| Other Pre-specified | 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 numerical rating scale (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. | Sample size was too small to conduct outcome analysis | Posted | 72 hours post-operatively |
|
Adverse event data was collected for 72 hours post-operatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Males Single shot peripheral nerve block | 0 | 0 | 0 | 0 | ||
| EG001 | 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). bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair. Females Single shot peripheral nerve block | 0 | 0 | 0 | 0 | ||
| EG002 | 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. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | 0 | 0 | 0 | 0 | ||
| EG003 | 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. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. | 0 | 1 | 0 | 1 |
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Due limited enrollment and early termination of this study, analysis of outcome data was not possible.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harshad Gurnaney, MBBS, MPH | Children's Hospital of Philadelphia | 215-590-1858 | gurnaney@email.chop.edu |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000698 | Analgesia |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000760 | Anesthesia and Analgesia |
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| >=65 years |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
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. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| OG003 | 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. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
|
| OG002 |
| 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. continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
| OG003 | 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. continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair. |
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