Anesthesia, Caudal
Conditions
Keywords
caudal block, wound infiltration, postoperative pain, outpatient surgery
Brief summary
Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration
Detailed description
Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours . Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis. Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.
Interventions
None listed
Sponsors
University Hospital Tuebingen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 68 Months
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
* no return of questionnaire * parents do not understand language
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Analgesia Quality Between the Two Groups | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Set up Time | Time in minutes measured between start of induction of anesthesia to start of surgical incision | How much times goes by for induction of anesthesia in both groups |
| Rescue Medication | 24 hours | total number of analgesic doses across all participants |
| Neurological Outcome | 24 hours | Time until first micturation an time to motor activity |
Participant flow
Recruitment details
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,
Pre-assignment details
Causes for exclusion from the study No return of Questionaire (n=31) Not meeting criteria for anaesthesia (n=3)
Participants by arm
| Arm | Count |
|---|---|
| Caudal Block (CB) Caudal Block (CB)
pain management
1 ml kg-1 ropivacaine and clonidine 2 ug kg-1 | 47 |
| Local Infiltration (LI) Local Infiltration (LI) pain management 0.375% 0.5 ml kg-1 ropivacaine injected subcutaneously | 39 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 14 |
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | Total | Caudal Block (CB) | Local Infiltration (LI) |
|---|---|---|---|
| Age, Continuous | 25.5 month STANDARD_DEVIATION 16.75 | 21 month STANDARD_DEVIATION 14.7 | 30 month STANDARD_DEVIATION 18.8 |
| Region of Enrollment Germany | 86 participants | 47 participants | 39 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 79 Participants | 44 Participants | 35 Participants |
| Weight of Children | 11 kilogram | 10 kilogram | 12 kilogram |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 22 |
| other Total, other adverse events | 2 / 30 | 3 / 22 |
| serious Total, serious adverse events | 0 / 30 | 0 / 22 |
Outcome results
Primary
Comparison of Analgesia Quality Between the Two Groups
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
Time frame: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | Arrival PCU | 1.86 score on a scale | Standard Error 0.43 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | Arrival ward | 1.83 score on a scale | Standard Error 0.5 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 1h | 1.36 score on a scale | Standard Error 0.31 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 2h | 1.3 score on a scale | Standard Error 0.33 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 3h | 1.43 score on a scale | Standard Error 0.31 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 4h | 2.0 score on a scale | Standard Error 0.34 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 5h | 1.76 score on a scale | Standard Error 0.34 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 6h | 1.5 score on a scale | Standard Error 0.28 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 12h | 1.56 score on a scale | Standard Error 0.35 |
| Caudal Block | Comparison of Analgesia Quality Between the Two Groups | 24 h | 0.56 score on a scale | Standard Error 0.22 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 6h | 1.00 score on a scale | Standard Error 0.33 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | Arrival PCU | 3.09 score on a scale | Standard Error 0.51 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 4h | 0.86 score on a scale | Standard Error 0.4 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | Arrival ward | 2.95 score on a scale | Standard Error 0.58 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 24 h | 0.68 score on a scale | Standard Error 0.26 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 1h | 2.13 score on a scale | Standard Error 0.37 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 5h | 0.77 score on a scale | Standard Error 0.4 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 2h | 1.68 score on a scale | Standard Error 0.39 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 12h | 1.31 score on a scale | Standard Error 0.41 |
| Local Infiltration | Comparison of Analgesia Quality Between the Two Groups | 3h | 1.54 score on a scale | Standard Error 0.36 |
p-value: <0.05ANCOVA
Secondary
Neurological Outcome
Time until first micturation an time to motor activity
Time frame: 24 hours
Secondary
Rescue Medication
total number of analgesic doses across all participants
Time frame: 24 hours
Population: The need for rescue medicine is an indirect parameter for the effectiveness of the analgesic procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caudal Block | Rescue Medication | 58 total number analgesic dosis |
| Local Infiltration | Rescue Medication | 31 total number analgesic dosis |
Secondary
Set up Time
How much times goes by for induction of anesthesia in both groups
Time frame: Time in minutes measured between start of induction of anesthesia to start of surgical incision
Population: to analyze which procedure is less time consuming
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Caudal Block | Set up Time | 22.5 minutes |
| Local Infiltration | Set up Time | 17 minutes |
p-value: <0.05Chi-squared