Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacain -Caudal | Active Comparator | Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%. |
|
| Bupivacain- Local | Active Comparator | Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacain- Caudal | Procedure | Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Analgesic Requirement | 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 | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The total number of oral acetaminophen | Total number of analgesic requirement | The number of analgesic received for the period of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10). | 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative |
| Motor block |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Gavrilovska-Brzanov, MD. Msc | Mother Theresa University Clinical Center Skopje Macedonia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uctoariced | Skopje | 1000 | North Macedonia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 9, 2016 | |
| Reset | Feb 8, 2016 | |
| Release | Feb 22, 2016 | |
| Unrelease | Yes |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2016 | Feb 8, 2016 | |||
| Feb 22, 2016 |
Not provided
Not provided
Not provided
Not provided
| Bupivacaine- Local | Procedure | Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml). |
|
|
Motor function was assessed using the following scale: 0, no motor block; 1, able to move legs; 2, unable to move legs. |
| 30 minutes postoperative, 1 hour postoperative, 2 hour postoperative, 3 hour postoperative, 6 hour postoperative , 12 hours postoperative, 24 post operative |
| Yes |