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Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01380834
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : May 21, 2015
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mihaela Visoiu, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE June 22, 2011
First Posted Date  ICMJE June 27, 2011
Results First Submitted Date  ICMJE April 16, 2015
Results First Posted Date  ICMJE May 21, 2015
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
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 ( mcg/kg) 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 paper record that accompanies the PCA pump is accurate for dilaudid consumption 12 hours post procedure. This record will be used for every subject enrolled in this study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS). [ Time Frame: 24 hrs after blocks were done or until the patient is discharged ]
Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block. 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 intraoperatively and 24 hours postoperatively (or until the patient is discharged, if sooner). We look also at possible side effects from opioids administration and possible complications associated with nerve blocks( % of patients in every group )
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients
Official Title  ICMJE Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy: a Prospective, Randomized Clinical Study
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: control 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%.
    Other Name: = Group 2(control group)
  • Drug: 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.
    Other Name: Group 1 ( treatment group)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: treatment group
  • 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%.
    Intervention: Drug: control group
Publications * Visoiu M, Cassara A, Yang CI. Bilateral Paravertebral Blockade (T7-10) Versus Incisional Local Anesthetic Administration for Pediatric Laparoscopic Cholecystectomy: A Prospective, Randomized Clinical Study. Anesth Analg. 2015 May;120(5):1106-13. doi: 10.1213/ANE.0000000000000545.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2011)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380834
Other Study ID Numbers  ICMJE PRO10060554
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mihaela Visoiu, University of Pittsburgh
Study Sponsor  ICMJE Mihaela Visoiu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mihaela Visoiu, MD CHP of UPMC
PRS Account University of Pittsburgh
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP