Nebulized Analgesia for Laparoscopic Appendectomy Trial

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Montreal Children's Hospital of the MUHC
• Treatments: Ropivacaine

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