Trial Outcomes & Findings for Peripheral Nerve Blocks in Pediatric Orthopedic Patients (NCT NCT02236130)
NCT ID: NCT02236130
Last Updated: 2017-02-13
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
day 2 and day 8 after the surgery
Results posted on
2017-02-13
Participant Flow
Participant milestones
| Measure |
General
General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Regional
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
27
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
General
General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Regional
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
Baseline Characteristics
Peripheral Nerve Blocks in Pediatric Orthopedic Patients
Baseline characteristics by cohort
| Measure |
General
n=22 Participants
General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Regional
n=27 Participants
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.55 years
n=5 Participants
|
11.41 years
n=7 Participants
|
11.02 years
n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Gender
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 2 and day 8 after the surgeryOutcome measures
| Measure |
General
n=15 Participants
General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Regional
n=15 Participants
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
|---|---|---|
|
Total Hydrocodone Dose (mg/kg)
Day 2 Total hydrocodone use in mg/kg
|
1.22 mg/kg
Standard Deviation 0.67
|
1.36 mg/kg
Standard Deviation 0.49
|
|
Total Hydrocodone Dose (mg/kg)
Day 8 Total hydrocodone use in mg/kg
|
1.45 mg/kg
Standard Deviation 0.82
|
2.15 mg/kg
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: one week after the surgeryPatient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.
Outcome measures
| Measure |
General
n=11 Participants
General Anesthesia only
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
Regional
n=12 Participants
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
|
|---|---|---|
|
Patient/Family Satisfaction With Pain Management
|
10 Participants
|
11 Participants
|
Adverse Events
General
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regional
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Madhankumar Sathyamoorthy
University of Mississippi Medical Center
Phone: 6018157066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place