Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01380834
Eligibility Criteria:
Inclusion Criteria:
* pediatric patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
* 8-17 yrs, female and male
* ASA 1, 2, 3
* more than 30 Kg
* BMI less than 36 (to calculate will use http://www.globalrph.com/bmi.htm )
* the patient must be able to self administer opioids via patient control analgesia (PCA)
* the patient must be able to complete postoperative questionnaires for pain score, pain type, location, patient satisfaction
* the patient will to be admitted for 24 hrs after surgery
Exclusion Criteria:
* patient refusal
* parental/guardian refusal
* history of coagulopathy, INR more than 1.5, platelets less than 100 000, PT , PTT more than normal value, patient on Coumadin, heparin or low molecular weight heparin ( LMWH)
* local infection at the planned block site
* vertebral anomalies, (e.g. scoliosis)
* BMI more or equal 36
* patient unable to self administer medications via PCA
* allergy to dilaudid, oxycodone, acetaminophen, ropivacaine
* chronic opioid use
* current weight less than 30 kg
* acute pain (pain on day of surgery that requires pain medication)
* pregnancy test positive
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT01380834
Study Brief:
Protocol Section:
NCT01380834