Uctoariced
Skopje, 1000, North Macedonia
NCT Number: NCT02620566
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).
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Notify Me6 month–7 year
All sexes
Interventional
Phase 1 / Phase 2
Skopje, 1000, North Macedonia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
Other names: Caudal block
Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
Other names: Local Wound Infiltration
Time frame: 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
Time frame: The number of analgesic received for the period of 24 hours
Total number of analgesic requirement
Time frame: 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).
Time frame: 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.
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
Other
Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration
Acronym: CBvsLWI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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