Nebulized Analgesia for Laparoscopic Appendectomy Trial
NALA
Evaluation of the Effect of Intraperitoneal Nebulized Ropivacaine on Morphine Consumption After Laparoscopic Appendectomy in Children. A Prospective, Randomized Double Blind Clinical Trial
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 8, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedMarch 22, 2016
March 1, 2016
1.4 years
December 3, 2015
March 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative morphine consumption
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.
During hospital admission (24-48 hours)
Secondary Outcomes (5)
Post-operative Pain
During hospital admission (24-48 hours)
Time to unassisted walking
During hospital admission (24-48 hours)
In-hospital length of stay
During hospital admission (24-48 hours)
Postoperative recovery quality
Two weeks after hospital discharge
Surgeon satisfaction
Immediately after surgery
Study Arms (3)
Ropivacaine Group
EXPERIMENTALThis 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.
Placebo group
PLACEBO COMPARATORThis 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.
Non-enrolled group
NO INTERVENTIONThis group will not receive either intervention (ropivicaine) or placebo (normal saline), but will have primary and secondary endpoints evaluated.
Interventions
Ropivicaine will be administered via in-line nebulization using the Aeroneb Pro™ system
Normal saline will be administered via in-line nebulization using the Aeroneb Pro™ system
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1, Canada
Related Publications (1)
Baird R, Ingelmo P, Wei A, Meghani Y, Perez EV, Pelletier H, Auer G, Mujallid R, Emil S, Laberge JM, Puligandla P, Shaw K, Poenaru D. Nebulized analgesia during laparoscopic appendectomy (NALA): A randomized triple-blind placebo controlled trial. J Pediatr Surg. 2019 Jan;54(1):33-38. doi: 10.1016/j.jpedsurg.2018.10.029. Epub 2018 Oct 5.
PMID: 30366723DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Baird, MDCM MSc
Assistant Professor of Pediatric Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatric Surgery
Study Record Dates
First Submitted
December 3, 2015
First Posted
December 8, 2015
Study Start
January 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
March 22, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share