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Nebulized Analgesia for Laparoscopic Appendectomy Trial (NALA)

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: NCT02624089
Recruitment Status : Unknown
Verified March 2016 by Robert Baird, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
Montreal Children's Hospital of the MUHC
Information provided by (Responsible Party):
Robert Baird, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The objective of this study is to assess whether the administration of nebulized intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces morphine consumption after laparoscopic appendectomy surgery in children and adolescents.

Condition or disease Intervention/treatment Phase
Appendicitis Drug: Ropivacaine Drug: Normal saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Intraperitoneal Nebulized Ropivacaine on Morphine Consumption After Laparoscopic Appendectomy in Children. A Prospective, Randomized Double Blind Clinical Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: Ropivacaine Group
This group will receive nebulized ropivacaine 0.5% based on ideal body weight at a dose of 0.5 mg/kg with a maximum total dose of 30 mg. This will be administered once at the onset of pneuomoperitoneum during appendectomy.
Drug: Ropivacaine
Ropivicaine will be administered via in-line nebulization using the Aeroneb Pro™ system
Other Name: Naropin

Placebo Comparator: Placebo group
This group will receive placebo (normal saline) based on ideal body weight at a dose of 0.5 mg/kg with a maximum total dose of 30 mg. This will be administered at the onset of pneuomoperitoneum during appendectomy.
Drug: Normal saline
Normal saline will be administered via in-line nebulization using the Aeroneb Pro™ system
Other Name: 0.9% saline

No Intervention: Non-enrolled group
This group will not receive either intervention (ropivicaine) or placebo (normal saline), but will have primary and secondary endpoints evaluated.



Primary Outcome Measures :
  1. Post-operative morphine consumption [ Time Frame: During hospital admission (24-48 hours) ]
    The total dose of Morphine (in mg/kg) and the route of administration received after surgery will be recorded. The oral morphine dose will be converted as 1mg IV= 2mg PO.


Secondary Outcome Measures :
  1. Post-operative Pain [ Time Frame: During hospital admission (24-48 hours) ]
    This will be serially evaluated using a Visual Analog Score

  2. Time to unassisted walking [ Time Frame: During hospital admission (24-48 hours) ]
  3. In-hospital length of stay [ Time Frame: During hospital admission (24-48 hours) ]
  4. Postoperative recovery quality [ Time Frame: Two weeks after hospital discharge ]
    This will be evaluated via a standardized telephone questionnaire

  5. Surgeon satisfaction [ Time Frame: Immediately after surgery ]
    this will be evaluated via a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents aged 7-18 years old
  • ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient.
  • ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
  • Patients scheduled for laparoscopic appendectomy surgery
  • Uncomplicated appendicitis

    • Hemodynamically stable patient
    • No evidence of appendiceal perforation based on preoperative clinical and imaging assessment
    • Diagnosed to have simple acute appendicitis by intraoperative laparoscopy
  • Patients who have provided a written informed assent
  • Caregivers who have provided a written informed consent

Exclusion Criteria:

  • ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
  • ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
  • ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
  • Hemodynamically unstable patient
  • Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment
  • Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery
  • Postoperative admission in an intensive care unit with sedation or ventilatory assistance
  • Cognitive impairment or mental retardation
  • Progressive degenerative diseases of the CNS
  • Seizures or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Allergy to one of the specific drugs under study
  • Alcohol or drug addiction
  • Failure to successfully undergo a laparoscopic appendectomy
  • A significant communication problem including language barrier, precluding phone follow up
  • Participation in a concomitant research study
  • Inability to assure complete follow up
  • Failure to acquire informed consent and assent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624089


Contacts
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Contact: Robert Baird, MDCM MSc 514 412 4400 ext 24438 robert.baird@mcgill.ca
Contact: Pablo Ingelmo, MD 514 412 4400 ext 24886 pablo.ingelmo@mcgill.ca

Locations
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Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Robert Baird, MDCM MSc    514 412 4400 ext 24438    robert.baird@mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Montreal Children's Hospital of the MUHC
Investigators
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Principal Investigator: Robert Baird, MDCM MSc Assistant Professor of Pediatric Surgery
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Baird, Assistant Professor of Pediatric Surgery, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02624089    
Other Study ID Numbers: 14-120-PED
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents