- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01380834
Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy: a Prospective, Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pain after laparoscopic cholecystectomy is a result of many mechanisms such as tissue injury, local trauma to gallbladder removal, chemical irritation of the peritoneum, pneumoperitoneum. Effective analgesia in the immediate post-operative period following laparoscopic cholecystectomy is necessary for optimal recovery. Many methods for pain control after laparoscopic cholecystectomy have been evaluated, but none of them provided optimal postoperative analgesia. When used as a complement to general anesthesia, bilateral paravertebral blockade T5-T6 for adult laparoscopic cholecystectomy has been found to improve postoperative pain control. Whether this is also the case with pediatric patients is not certain. Analgesia from administration of local anesthetic by surgeon at insufflations ports is of short duration and may not provide sufficient pain relief. cholecystectomy.
84 pediatric patients (8-17 yrs old) will be randomly assigned to two groups: Group 1 (treatment group): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5%, and incisional administration of placebo / normal saline at all four laparoscopic ports.
Group 2 (control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all for insufflation ports with ropivacaine 0.5%.
Both the anesthesiologist and the surgeon will be blinded to patient randomization.
Additional postoperative pain control will be provided via patient administered dilaudid PCA, for 12 hours after paravertebral block. After PCA is discontinued, the patient will receive oxycodone po and dilaudid iv for breakthrough pain.
Pain assessment will continue until 24 hours after paravertebral block or patient discharge if earlier than 24 hours.
The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
The secondary end points will be also for total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used intraoperatively and 24 hours postoperatively (or until the patient is discharged, if sooner).
Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block using Visual Analog Scale (VAS).
Other secondary end-points will be possible side effects from opioids administration (nausea, emesis, itching, and episodes of respiratory depression) and possible complications associated with nerve blocks: pleural and vascular punctures, pneumothorax, back pain, bruises, and intravascular administration of local anesthetic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh, UPMC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: treatment group
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
|
Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
Other Names:
|
Placebo Comparator: Placebo group
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
|
Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioids Consumption Via PCA
Time Frame: 12 hrs after the blocks were done
|
The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
|
12 hrs after the blocks were done
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
Time Frame: 24 hrs after blocks were done or until the patient is discharged
|
The VAS (Visual Analog Scale, 0 mm "no pain", to 100 mm," the worst pain possible ") is used to assess postoperative pain for patients.
Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.
|
24 hrs after blocks were done or until the patient is discharged
|
Opioid Consumption
Time Frame: 24 hrs after blocks were done or until the patient is discharged
|
Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).
|
24 hrs after blocks were done or until the patient is discharged
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mihaela Visoiu, MD, CHP of UPMC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO10060554
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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