Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

Anesthesia Clinical Trial

— CBvsLWI  

Official title:

Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620566
• Other study ID #: UCTOARICED1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 20, 2015
• Last updated: January 3, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Hernia

Intervention

Procedure:
• Bupivacain- Caudal
Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
• Bupivacaine- Local
Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).

Locations

Country	Name	City	State
Macedonia, The Former Yugoslav Republic of	Uctoariced	Skopje

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic for Anesthesia Reanimation and Intensive Care Mother Theresa

Country where clinical trial is conducted

Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Motor block	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
Primary	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
Secondary	The total number of oral acetaminophen	Total number of analgesic requirement	The number of analgesic received for the period of 24 hours