Trial Outcomes & Findings for Caudal Block Versus Local Wound Infiltration for Inguinal Procedures (NCT NCT04590027)
NCT ID: NCT04590027
Last Updated: 2021-07-14
Results Overview
Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management
Recruitment status
COMPLETED
Target enrollment
86 participants
Primary outcome timeframe
Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,
Results posted on
2021-07-14
Participant Flow
The clinical trial was conducted at the University Hospital of Tuebingen, Germany, where paediatric inguinal procedures in children classified as ASA I or ASA II ( American Society of Anesthesiologists Physical Status System) are performed in an outpatient setting. Recruitment period:Between February 2014 and June 2015,
Causes for exclusion from the study No return of Questionaire (n=31) Not meeting criteria for anaesthesia (n=3)
Participant milestones
| Measure |
Caudal Block
Caudal anaesthesia was performed after induction of anaesthesia. The puncture site was preoperatively anesthetized with Eutetic Mixture of Local Anaesthetics (EMLA®). The patient was then placed in a lateral decubitus position with left side down. An Epican® Paed 23G Tuohy needle was inserted into the epidural space using anatomical landmarks. After negative aspiration, a combination of a local anaesthetic (1 ml kg-1 ropivacaine 0,2%) and clonidine (2 μg kg-1) was applied.
|
Local Infiltration (LI)
In patients randomised to the Local Infiltration group (LI) ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
39
|
|
Overall Study
COMPLETED
|
30
|
22
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Caudal Block
Caudal anaesthesia was performed after induction of anaesthesia. The puncture site was preoperatively anesthetized with Eutetic Mixture of Local Anaesthetics (EMLA®). The patient was then placed in a lateral decubitus position with left side down. An Epican® Paed 23G Tuohy needle was inserted into the epidural space using anatomical landmarks. After negative aspiration, a combination of a local anaesthetic (1 ml kg-1 ropivacaine 0,2%) and clonidine (2 μg kg-1) was applied.
|
Local Infiltration (LI)
In patients randomised to the Local Infiltration group (LI) ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
14
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
The random sample was 52 patients. 34 patients were excluded.
Baseline characteristics by cohort
| Measure |
Caudal Block (CB)
n=47 Participants
Caudal Block (CB)
pain management
1 ml kg-1 ropivacaine and clonidine 2 ug kg-1
|
Local Infiltration (LI)
n=39 Participants
Local Infiltration (LI) pain management 0.375% 0.5 ml kg-1 ropivacaine injected subcutaneously
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21 month
STANDARD_DEVIATION 14.7 • n=30 Participants • The random sample was 52 patients. 34 patients were excluded.
|
30 month
STANDARD_DEVIATION 18.8 • n=22 Participants • The random sample was 52 patients. 34 patients were excluded.
|
25.5 month
STANDARD_DEVIATION 16.75 • n=52 Participants • The random sample was 52 patients. 34 patients were excluded.
|
|
Sex: Female, Male
Female
|
3 Participants
n=47 Participants
|
4 Participants
n=39 Participants
|
7 Participants
n=86 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=47 Participants
|
35 Participants
n=39 Participants
|
79 Participants
n=86 Participants
|
|
Region of Enrollment
Germany
|
47 participants
n=47 Participants
|
39 participants
n=39 Participants
|
86 participants
n=86 Participants
|
|
Weight of Children
|
10 kilogram
n=30 Participants • Thirty-one patients had to be excluded from the analysis because the parents did not return the questionnaire. Another three patients were excluded because the specified anaesthesia protocol was not followed.
|
12 kilogram
n=22 Participants • Thirty-one patients had to be excluded from the analysis because the parents did not return the questionnaire. Another three patients were excluded because the specified anaesthesia protocol was not followed.
|
11 kilogram
n=52 Participants • Thirty-one patients had to be excluded from the analysis because the parents did not return the questionnaire. Another three patients were excluded because the specified anaesthesia protocol was not followed.
|
PRIMARY outcome
Timeframe: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management
Outcome measures
| Measure |
Caudal Block
n=30 Participants
Ropivacaine 0,2 % 1 ml kg-1 and clonidine 2 μg kg-1
|
Local Infiltration
n=22 Participants
Ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously
|
|---|---|---|
|
Comparison of Analgesia Quality Between the Two Groups
4h
|
2.0 score on a scale
Standard Error 0.34
|
0.86 score on a scale
Standard Error 0.40
|
|
Comparison of Analgesia Quality Between the Two Groups
24 h
|
0.56 score on a scale
Standard Error 0.22
|
0.68 score on a scale
Standard Error 0.26
|
|
Comparison of Analgesia Quality Between the Two Groups
Arrival PCU
|
1.86 score on a scale
Standard Error 0.43
|
3.09 score on a scale
Standard Error 0.51
|
|
Comparison of Analgesia Quality Between the Two Groups
Arrival ward
|
1.83 score on a scale
Standard Error 0.5
|
2.95 score on a scale
Standard Error 0.58
|
|
Comparison of Analgesia Quality Between the Two Groups
1h
|
1.36 score on a scale
Standard Error 0.31
|
2.13 score on a scale
Standard Error 0.37
|
|
Comparison of Analgesia Quality Between the Two Groups
2h
|
1.3 score on a scale
Standard Error 0.33
|
1.68 score on a scale
Standard Error 0.39
|
|
Comparison of Analgesia Quality Between the Two Groups
3h
|
1.43 score on a scale
Standard Error 0.31
|
1.54 score on a scale
Standard Error 0.36
|
|
Comparison of Analgesia Quality Between the Two Groups
5h
|
1.76 score on a scale
Standard Error 0.34
|
0.77 score on a scale
Standard Error 0.40
|
|
Comparison of Analgesia Quality Between the Two Groups
6h
|
1.5 score on a scale
Standard Error 0.28
|
1.00 score on a scale
Standard Error 0.33
|
|
Comparison of Analgesia Quality Between the Two Groups
12h
|
1.56 score on a scale
Standard Error 0.35
|
1.31 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Time in minutes measured between start of induction of anesthesia to start of surgical incisionPopulation: to analyze which procedure is less time consuming
How much times goes by for induction of anesthesia in both groups
Outcome measures
| Measure |
Caudal Block
n=30 Participants
Ropivacaine 0,2 % 1 ml kg-1 and clonidine 2 μg kg-1
|
Local Infiltration
n=22 Participants
Ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously
|
|---|---|---|
|
Set up Time
|
22.5 minutes
Interval 16.0 to 46.0
|
17 minutes
Interval 10.0 to 35.0
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The need for rescue medicine is an indirect parameter for the effectiveness of the analgesic procedure.
total number of analgesic doses across all participants
Outcome measures
| Measure |
Caudal Block
n=30 Participants
Ropivacaine 0,2 % 1 ml kg-1 and clonidine 2 μg kg-1
|
Local Infiltration
n=22 Participants
Ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously
|
|---|---|---|
|
Rescue Medication
|
58 total number analgesic dosis
|
31 total number analgesic dosis
|
SECONDARY outcome
Timeframe: 24 hoursTime until first micturation an time to motor activity
Outcome measures
Outcome data not reported
Adverse Events
Caudal Block
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Local Infiltration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caudal Block
n=30 participants at risk
Caudal anaesthesia was performed after induction of anaesthesia. The puncture site was preoperatively anesthetized with EMLA®. The patient was then placed in a lateral decubitus position with left side down. An Epican® Paed 23G Tuohy needle was inserted into the epidural space using anatomical landmarks. After negative aspiration, a combination of a local anaesthetic (1 ml kg-1 ropivacaine 0,2%) and clonidine (2 μg kg-1) was applied.
|
Local Infiltration
n=22 participants at risk
In patients randomised to the LI group ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.
|
|---|---|---|
|
Gastrointestinal disorders
vomiting
|
6.7%
2/30 • Number of events 2 • 0-24 h postoperatively
|
13.6%
3/22 • Number of events 3 • 0-24 h postoperatively
|
|
Renal and urinary disorders
delayed micturation
|
0.00%
0/30 • 0-24 h postoperatively
|
0.00%
0/22 • 0-24 h postoperatively
|
Additional Information
Dr. Barbara Schlisio
University of Tuebingen, Department of Anaesthesiology and Intensive Care Medicine
Phone: +4970712985535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place