EBULISED INTRAPERITONEAL LOCAL ANAESTHETIC (NILA) FOR LAPAROSCOPIC SURGERY: A PROSPECTIVE, RANDOMISED, DOUBLE BLINDED, PLACEBO CONTROLLED CLINICAL TRIAL - NILA

Conditions: Post operative shoulder tip pain following laparoscopic appendectomy, cholecystectomy, laparoscopic Nissen fundoplication or diagnostic laparoscopy.

Registration Number: EUCTR2009-015236-15-IE

Lead Sponsor: Department of Surgery, National University of Ireland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

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

-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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>- To determine whether or not intraperitoneal nebulised ropivacaine is effective for the prevention of nausea and vomiting following laparoscopic procedures. <br>- 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.

Secondary Outcome Measures