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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mihaela Visoiu, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01380834
First received: June 22, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Pain, Postoperative
Drug: control group
Drug: treatment group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy: a Prospective, Randomized Clinical Study

Further study details as provided by Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • opioids consumption via PCA [ Time Frame: 12 hrs after the blocks were done ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Postoperative pain scores assessed using Visual Analog Scale ( VAS). [ Time Frame: 24 hrs after blocks were done or until the patient is discharged ] [ Designated as safety issue: No ]

    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 )



Enrollment: 84
Study Start Date: November 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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%.
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)

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 ( 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 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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380834

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh, UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Mihaela Visoiu, MD CHP of UPMC
  More Information

No publications provided

Responsible Party: Mihaela Visoiu, Clinical Assistant Professor, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT01380834     History of Changes
Obsolete Identifiers: NCT01231048
Other Study ID Numbers: PRO10060554
Study First Received: June 22, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
paravertebral nerve blocks
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Anesthetics, Local
Ropivacaine
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014