N/A
N=84
Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT01380834 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Opioids Consumption Via PCA — 107.29; 100.17 ng/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- control group (Drug); treatment group (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Mihaela Visoiu
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioids Consumption Via PCA |
107.29; 100.17 | — |
| SECONDARY Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS). |
42.68; 38.95; 46.69; 37.67; 43.88; 36.07 | — |
| SECONDARY Opioid Consumption |
0.73; 0.71 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT01380834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.