Trial record 4 of 68 for:    Open Studies | "Cholecystectomy"

Bilateral Paravertebral Blockade vs. Incisional Local Anesthetic Administration for Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Children's Hospital of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01231048
First received: October 29, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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 After Laparoscopic Cholecystectomy
Procedure: paravertebral nerve blocks, single shot
Procedure: incisional administration of ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The total of opioids use in both groups [ Time Frame: 24 hours after the blocks are done ] [ Designated as safety issue: No ]

    The main outcome variables that will be compared between 2 groups are:

    • Fentanyl (mcg/kg) administered during surgery.
    • Dilaudid (mcg/kg) given via PCA (total)
    • Dilaudid (mcg/kg) given via PCA at the end of 4,8,12 hrs after blocks.
    • Oxycodone po (mg/kg) at the end of 18 hrs and total
    • Dilaudid (mcg/kg) administered for breakthrough pain after PCA is discontinued at the end of 18 hrs and total
    • Total morphine administered (mcg/kg) after conversion of fentanyl, dilaudid and oxycodone to morphine (based on opioids potency) .


Secondary Outcome Measures:
  • pain score [ Time Frame: 24 hrs after the blocks are done ] [ Designated as safety issue: No ]
    Response on 100 mm Visual Analog Scale (VAS )will be compared between 2 groups at 4, 8, 12, 18 and 24 hrs (or when the patient is discharged, if sooner).

  • side effects from opioids administration [ Time Frame: 24 hours after the blocks are done ] [ Designated as safety issue: Yes ]
    To compare possible side effects from opioids administration (nausea, emesis, itching, and episodes of respiratory depression) between these 2 groups.

  • complications from paravertebral nerve blocks [ Time Frame: 24 hours after the blocks are done ] [ Designated as safety issue: Yes ]
    The possible complications associated with nerve blocks: pleural and vascular punctures, pneumothorax, back pain, bruises, and intravascular administration of local anesthetic will be compared between 2 groups.

  • type of postoperative pain [ Time Frame: 24 hours after the blocks are done ] [ Designated as safety issue: No ]
    The type of postoperative pain (parietal, visceral, shoulder pain) after laparoscopic cholecystectomy will be assessed and compared in these two groups.

  • the patient's satisfaction [ Time Frame: 24 hours after the blocks are done ] [ Designated as safety issue: No ]
    The patient's satisfaction will be assessed and compared in these two groups.


Estimated Enrollment: 84
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: paravertebral nerve blocks, single shot
    Every patient will have ropivacaine 0.5 %/placebo, 0.1 ml/kg, maximum 5 ml administered at 6 paravertebral levels and placebo/ropivacaine 0.5 % , 0.1 ml/kg, and maximum 5 ml, at each of the 4 laparoscopic ports.
    Procedure: incisional administration of ropivacaine
    Every patient will have ropivacaine 0.5 %/placebo, 0.1 ml/kg, maximum 5 ml administered at 6 paravertebral levels and placebo/ropivacaine 0.5 % , 0.1 ml/kg, and maximum 5 ml, at each of the 4 laparoscopic ports.
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.

Research design, specific aims and methods:

The primary end-point of this research is to determine which technique is better for postoperative pain control after laparoscopic cholecystectomy.

Screening: 100 pediatric patients (8-17 yrs old) coming for elective laparoscopic 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 2 groups will be compared for total amount of fentanyl, dilaudid, oxycodone and morphine (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.

The secondary end-points will include 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.

In addition, the type of postoperative pain (parietal, visceral, shoulder pain) after laparoscopic cholecystectomy and patient's satisfaction will be assessed and compared in these two groups.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 35
  • 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 than 35
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231048

Contacts
Contact: Mihaela Visoiu, MD 412 692 5260 visoium@upmc.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15201
Contact: Mihaela Visoiu, MD    412-692-5260    visoium@upmc.edu   
Principal Investigator: Mihaela Visoiu, MD         
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Mihaela Visoiu, MD Children's Hospital of Pittsburgh of UPMC
  More Information

Publications:
Responsible Party: Mihaela Visoiu, Assistant Professor of Anesthesiology, Children's Hospital of Pittsburgh of UPMC
ClinicalTrials.gov Identifier: NCT01231048     History of Changes
Other Study ID Numbers: PRO 10060554
Study First Received: October 29, 2010
Last Updated: October 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
postoperative pain
laparoscopic cholecystectomy
paravertebral nerve blocks
pediatric patients
incisional local anesthetic administration

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014