Pain Clinical Trial
Official title:
Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles
Verified date | January 2023 |
Source | University of Jordan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 20, 2022 |
Est. primary completion date | April 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 36 Months |
Eligibility | Inclusion Criteria: - Age between 6 months and 36 months - Undergoing elective lower abdominal or perineal surgeries Exclusion Criteria: - Refusal of the legal guardian of the patient. - Patients aging less than 6 months, or older than 36 months. - Emergency surgeries. - Coagulopathy. - infection at the site of procedure. - Uncorrected hypovolemia. - Increased intracranial pressure. - Congenital anomalies at the site of procedure. |
Country | Name | City | State |
---|---|---|---|
Jordan | Jordan University Hospital | Amman |
Lead Sponsor | Collaborator |
---|---|
University of Jordan |
Jordan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioids requirements intraoperatively | The investigators will document the required dose of opioids intraoperatively | 90 minutes | |
Primary | Pain score in the post-anesthesia care unit (PACU) | Pain score will be assessed regularly during the stay in the PACU using a pain scoring scale, where the score is interpreted from 0 to 10, in which 0 means no pain and 10 signifies very severe pain. | 120 minutes | |
Primary | Peri-operative complications | Peri-operative complications related to the caudal block procedure will be documented from the start of the procedure till the discharge from the post-anesthesia care unit. | 210 minutes |
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