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
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Drug: Ropivacaine Drug: Normal saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
- Post-operative Pain [ Time Frame: During hospital admission (24-48 hours) ]This will be serially evaluated using a Visual Analog Score
- Time to unassisted walking [ Time Frame: During hospital admission (24-48 hours) ]
- In-hospital length of stay [ Time Frame: During hospital admission (24-48 hours) ]
- Postoperative recovery quality [ Time Frame: Two weeks after hospital discharge ]This will be evaluated via a standardized telephone questionnaire
- Surgeon satisfaction [ Time Frame: Immediately after surgery ]this will be evaluated via a questionnaire
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
|Contact: Robert Baird, MDCM MSc||514 412 4400 ext firstname.lastname@example.org|
|Contact: Pablo Ingelmo, MD||514 412 4400 ext email@example.com|
|Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H4A 3J1|
|Contact: Robert Baird, MDCM MSc 514 412 4400 ext 24438 firstname.lastname@example.org|
|Principal Investigator:||Robert Baird, MDCM MSc||Assistant Professor of Pediatric Surgery|