Trial Outcomes & Findings for A Comparison of UGSB and GA to IV Narcotics and GA for Post-Op Pain in Children With Supracondylar Fractures. (NCT NCT02056288)
NCT ID: NCT02056288
Last Updated: 2021-05-21
Results Overview
Opioid administration measured in mg/kg. Results below represent the total opioids given in the PACU, after discharge from the PACU, and then total post-operative period.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
78 participants
Primary outcome timeframe
up to 48 hours after surgery
Results posted on
2021-05-21
Participant Flow
Participant milestones
| Measure |
Ultrasound Guided Supraclavicular Block
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
In-Hospital Data
STARTED
|
40
|
38
|
|
In-Hospital Data
COMPLETED
|
35
|
38
|
|
In-Hospital Data
NOT COMPLETED
|
5
|
0
|
|
48-Hour Post-Discharge Data
STARTED
|
35
|
38
|
|
48-Hour Post-Discharge Data
COMPLETED
|
21
|
18
|
|
48-Hour Post-Discharge Data
NOT COMPLETED
|
14
|
20
|
Reasons for withdrawal
| Measure |
Ultrasound Guided Supraclavicular Block
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
In-Hospital Data
Surgery cancelled
|
1
|
0
|
|
In-Hospital Data
Protocol Violation
|
3
|
0
|
|
In-Hospital Data
Physician Decision
|
1
|
0
|
|
48-Hour Post-Discharge Data
Did not return diary
|
14
|
20
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ultrasound Guided Supraclavicular Block
n=35 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=38 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.52 years
n=35 Participants
|
6.01 years
n=38 Participants
|
6.09 years
n=73 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=35 Participants
|
17 Participants
n=38 Participants
|
32 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=35 Participants
|
21 Participants
n=38 Participants
|
41 Participants
n=73 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
35 participants
n=35 Participants
|
38 participants
n=38 Participants
|
73 participants
n=73 Participants
|
|
ASA Physical Status
ASA I
|
25 Participants
n=35 Participants
|
27 Participants
n=38 Participants
|
52 Participants
n=73 Participants
|
|
ASA Physical Status
ASA II
|
10 Participants
n=35 Participants
|
11 Participants
n=38 Participants
|
21 Participants
n=73 Participants
|
|
Weight
|
24.89 kg
STANDARD_DEVIATION 8.07 • n=35 Participants
|
23.75 kg
STANDARD_DEVIATION 5.43 • n=38 Participants
|
24.29 kg
STANDARD_DEVIATION 6.85 • n=73 Participants
|
PRIMARY outcome
Timeframe: up to 48 hours after surgeryPopulation: Total PACU consumption was able to be calculated for all subjects. Not every subject returned their 48-hour diary. As such, the discharge consumption does not reflect all possible subjects.
Opioid administration measured in mg/kg. Results below represent the total opioids given in the PACU, after discharge from the PACU, and then total post-operative period.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=35 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=38 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
Opioid Consumption
Total Intraoperative Opioids
|
0 mg/kg
Interval 0.0 to 0.09
|
0.2 mg/kg
Interval 0.11 to 0.26
|
|
Opioid Consumption
PACU - 1st 2 hours
|
0 mg/kg
Interval 0.0 to 0.05
|
0.12 mg/kg
Interval 0.06 to 0.22
|
|
Opioid Consumption
Home - Hour 2 to 48
|
0.25 mg/kg
Interval 0.0 to 0.53
|
0.04 mg/kg
Interval 0.0 to 0.53
|
|
Opioid Consumption
Total Opioid Consumption - PACU and Home
|
0.31 mg/kg
Interval 0.05 to 0.53
|
0.26 mg/kg
Interval 0.1 to 0.58
|
SECONDARY outcome
Timeframe: PACU Period up to 3 hoursPopulation: Reflects only subjects who requested analgesia in the PACU.
Time at which additional analgesia was requested and/or administered by the nurse while in the PACU. Discharge data not reported due to poor diary return compliance.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=9 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=35 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
Time of First Analgesia Request
|
76 Minutes
Interval 53.0 to 93.0
|
27 Minutes
Interval 13.0 to 43.0
|
SECONDARY outcome
Timeframe: From the time of PACU arrival up to time the patient achieves an Aldrete Score of 9- 10.Documented time that patient achieves an Aldrete Score of 9 -10. This is a standardized scale used to assess discharge readiness at Texas Children's Hospital.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=35 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=38 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
Time of Achieving Discharge Readiness
|
72 Minutes
Interval 30.0 to 125.0
|
94 Minutes
Interval 48.0 to 187.0
|
SECONDARY outcome
Timeframe: up to 48 hours after surgeryDocumented side effects such as nausea, vomiting, pruritus, and respiratory depression.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=35 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=38 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
Incidence of Side Effects
Nausea
|
1 Participants
|
0 Participants
|
|
Incidence of Side Effects
Vomiting
|
0 Participants
|
0 Participants
|
|
Incidence of Side Effects
Pruritus
|
0 Participants
|
0 Participants
|
|
Incidence of Side Effects
Respiratory Depression
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 48 hours after surgeryPopulation: Not all subjects returned their 48-hour diary.
Child subject and parent satisfaction with pain management was measured using the global perioperative experience graded on a numeric scale of 0 - 10, with 0 indicating poor management to 10 indicating excellent pain management. Satisfaction is reported at 12-, 24-, 48-hours, and overall at home.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=19 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=17 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
Patient and Parent Satisfaction
Child's Satisfaction - at 12-hours
|
5.8 units on a scale
Interval 0.0 to 10.0
|
6.6 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Child's Satisfaction - at 24-hours
|
5.6 units on a scale
Interval 0.0 to 10.0
|
5.6 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Child's Satisfaction - at 48-hours
|
7.5 units on a scale
Interval 0.0 to 10.0
|
7.1 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Child's Satisfaction - Total time at home
|
6.1 units on a scale
Interval 0.0 to 10.0
|
5.9 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Parent's Satisfaction - at 12-hours
|
5.8 units on a scale
Interval 0.0 to 10.0
|
7.1 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Parent's Satisfaction - at 24-hours
|
6.4 units on a scale
Interval 0.0 to 10.0
|
6.5 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Parent's Satisfaction - at 48-hours
|
8.1 units on a scale
Interval 0.0 to 10.0
|
7.6 units on a scale
Interval 0.0 to 10.0
|
|
Patient and Parent Satisfaction
Parent's Satisfaction - Total time at home
|
7.9 units on a scale
Interval 0.0 to 10.0
|
6.5 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: From admission to PACU to 48 hours after surgeryPopulation: Some subjects in the PACU did not have VNS collected. In addition, not all of the 48-hour diaries were returned to allow for at home calculations.
The Verbal Numeric Scale (VNS) asks patients to verbally state a number between 0 and 10 that corresponds to their present pain intensity. 0 = no pain and 10 = worst possible pain ever. Pain was measured by the child subject in the PACU at arrival, 15-, 30-, 60- and 120-minutes. Pain was assessed by the child subject and a parent at home at 12-, 24-, and 48-hours after surgery. The results represent a mean of all verbal pain scores in the PACU, while at home, and overall.
Outcome measures
| Measure |
Ultrasound Guided Supraclavicular Block
n=35 Participants
Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml), using the technique described by Marhofer et al. In order to decrease variance in success rates, the ultrasound guided nerve block will be performed by 1 of the 4 anesthesiology co-investigators, each of whom have successfully performed over 100 ultrasound guided blocks in the past. Supraclavicular blocks were performed using the higher frequency of the probe and placing it in a coronal-oblique-plane in the supraclavicular fossa.
Ropivacaine: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
|
IV Opioids
n=38 Participants
Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
|
|---|---|---|
|
The Mean Pain Score in the Postoperative Period
PACU
|
1.28 units on a scale
Standard Deviation 1.88
|
4.76 units on a scale
Standard Deviation 2.84
|
|
The Mean Pain Score in the Postoperative Period
Home
|
3.85 units on a scale
Standard Deviation 2.55
|
3.49 units on a scale
Standard Deviation 2.63
|
|
The Mean Pain Score in the Postoperative Period
PACU + Home
|
2.46 units on a scale
Standard Deviation 2.44
|
4.44 units on a scale
Standard Deviation 2.72
|
Adverse Events
Ultrasound Guided Supraclavicular Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IV Opioids
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
Chris D. Glover, MD, MBA, Principal Investigator
Baylor College of Medicine
Phone: 832-824-5800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place