Anesthesia
Conditions
Keywords
caudal block, local wound infiltration, hernia repair
Brief summary
To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).
Detailed description
Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI). Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.
Interventions
PROCEDUREBupivacain- Caudal
Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
PROCEDUREBupivacaine- Local
Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
Sponsors
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 7 Years
Healthy volunteers
No
Inclusion criteria
* 6 month to 7 years * ASA physical status I or II * undergoing unilateral hernia repair
Exclusion criteria
* history of developmental delay or mental retardation * type I diabetes * known or suspected coagulopathy * known allergy to any local anesthetic * known congenital anomaly of the spine * signs of spinal anomaly or infection at the sacral or inguinal region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Analgesic Requirement | 24 hours | The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total number of oral acetaminophen | The number of analgesic received for the period of 24 hours | Total number of analgesic requirement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative | Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10). |
| Motor block | 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative | Motor function was assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs. |
Countries
North Macedonia
Outcome results
None listed