Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Pain, Postoperative
In brief
The objective of this study is to assess the efficacy of paravertebral nerve blocks, single shot, with ropivacaine 0.5% for postoperative pain control after elective laparoscopic cholecystectomy as compared with incisional administration of same local anesthetic at laparoscopic insufflation ports by the surgeon.
Key facts
- Study ID
- NCT01380834
- Run by
- Mihaela Visoiu
- People needed
- 84
- Starts
- 2010-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-11-20
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Pittsburgh, UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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