Ultrasound Clinical Trial
Official title:
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial
Verified date | April 2024 |
Source | Tanta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.
Status | Completed |
Enrollment | 66 |
Est. completion date | April 21, 2024 |
Est. primary completion date | April 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 7 Years |
Eligibility | Inclusion Criteria: - Age: 2 months to 7 years old - Both sexes. - American Society of Anesthesiologists (ASA) I-II. - Schedule for elective unilateral inguinal hernia repair. Exclusion Criteria: - Patients with history of allergy. - Hepatic and renal failure. - Previous inguinal surgery. - Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum). |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | El-Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total postoperative pethidine consumption | The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is > 3, pethidine 0.5 mg/kg. | 24 hours postoperatively | |
Secondary | Post-operative pain scores | Face, Legs, Activity, Cry and Consolability (FLACC) scale will be used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain.
FLACC scale will be measured at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours. |
24 hours postoperatively | |
Secondary | Time of first analgesia request. | Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia. | 24 hours postoperatively | |
Secondary | Incidence of adverse events | Complication related to the block or adverse events of the administered drugs. | 24 hours postoperatively |
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