Post operative shoulder tip pain following laparoscopic appendectomy, cholecystectomy, laparoscopic Nissen fundoplication or diagnostic laparoscopy.
Conditions
Interventions
Trade Name: Naropin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ROPIVACAINE HYDROCHLORIDE
CAS Number: 84057-95-4
Other descriptive name: (2S)-N-(2,6-dimethylphenyl)-1-propylpiperi
Sponsors
Department of Surgery, National University of Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients undergoing any of the following procedures: -Laparoscopic appendectomy -Laparoscopic cholecystectomy -Laparoscopic Nissen fundoplication -Diagnostic laparoscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -ASA 3-5 -Regular NSAID or opioid use -History of drug abuse -Allergies to local anaesthetic -Conversion to open procedure -Pregnant or breast feeding women -Patients unable to provide their own consent (under the age of 18, cognitive impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether or not intraperitoneal nebulised ropivacaine is effective for the prevention of pain following laparoscopic procedures. ;Secondary Objective: - To measure serum levels of ropivacaine following nebulised intraperitoneal administration. - To determine whether or not intraperitoneal nebulised ropivacaine is effective for the prevention of nausea and vomiting following laparoscopic procedures. - To determine whether or not intraperitoneal nebulised ropivacaine is effective for reducing the duration of immobility and hospitalisation following laparoscopic procedures.;Primary end point(s): Shoulder tip pain at 6, 12, 24 and 48 hours following surgery. | — |
Countries
Ireland
Outcome results
None listed