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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01380834 |
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Date of registration:
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22/06/2011 |
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Primary sponsor: |
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Public title:
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Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
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Scientific title:
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Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy: a Prospective, Randomized Clinical Study |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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84 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01380834 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Mihaela Visoiu, MD |
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Address:
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Telephone:
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412-692-5260 |
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Email:
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m_visoiu@yahoo.com |
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Affiliation:
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Name:
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Mihaela Visoiu, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHP of UPMC |
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Key inclusion & exclusion criteria
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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
Age minimum:
8 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Drug: control group
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Drug: treatment group
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Primary Outcome(s)
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opioids consumption via PCA
[Time Frame: 12 hrs after the blocks were done]
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Secondary Outcome(s)
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Postoperative pain scores assessed using Visual Analog Scale ( VAS).
[Time Frame: 24 hrs after blocks were done or until the patient is discharged]
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Secondary ID(s)
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PRO10060554
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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