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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h, |
| Measure | Description | Time Frame |
|---|---|---|
| Set up Time | How much times goes by for induction of anesthesia in both groups | Time in minutes measured between start of induction of anesthesia to start of surgical incision |
| Rescue Medication |
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Inclusion Criteria:
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Exclusion Criteria:
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outpatient setting
paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of paediatric surgery
Causes for exclusion from the study No return of Questionaire (n=31) Not meeting criteria for anaesthesia (n=3)
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,
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caudal Block (CB) | Caudal Block (CB) pain management 1 ml kg-1 ropivacaine and clonidine 2 ug kg-1 |
| BG001 | Local Infiltration (LI) | Local Infiltration (LI) pain management 0.375% 0.5 ml kg-1 ropivacaine injected subcutaneously |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The random sample was 52 patients. 34 patients were excluded. |
| 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 | 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 | Posted | Mean | Standard Error | score on a scale | Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h, |
|
0-24 h postoperatively
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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 | Caudal Block | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment | vomiting |
Since postoperative pain and emergence delirium might overlap within the first half hour after the procedure, a paediatric anaesthesia emergence delirium scale might have been useful.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Schlisio | University of Tuebingen, Department of Anaesthesiology and Intensive Care Medicine | +4970712985535 | barbara.schlisio@med.uni-tuebingen.de |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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total number of analgesic doses across all participants
| 24 hours |
| Neurological Outcome | Time until first micturation an time to motor activity | 24 hours |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| month |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight of Children | weight measured in kg | 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. | Median | Inter-Quartile Range | kilogram |
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| Units | Counts |
|---|---|
| Participants |
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|
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| Secondary | Set up Time | How much times goes by for induction of anesthesia in both groups | to analyze which procedure is less time consuming | Posted | Median | Inter-Quartile Range | minutes | Time in minutes measured between start of induction of anesthesia to start of surgical incision |
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| Secondary | Rescue Medication | total number of analgesic doses across all participants | The need for rescue medicine is an indirect parameter for the effectiveness of the analgesic procedure. | Posted | Number | total number analgesic dosis | 24 hours |
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| Secondary | Neurological Outcome | Time until first micturation an time to motor activity | Not Posted | 24 hours | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Local Infiltration | In patients randomised to the LI group ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis. | 0 | 22 | 0 | 22 | 3 | 22 |
| delayed micturation | Renal and urinary disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |