Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy

Phase 3

Recruiting

Conditions: gallstones
10017943
symptomatic gallstone disease

Registration Number: NL-OMON33385

Lead Sponsor: Meander Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

The patients who will be included are 18-75 of age and ASA I&II, which means that no or mild systemic disease is present according to the classification system of the American Society of Anaesthesiologists. The patients are included when a surgeon sets the indication for a laparoscopic cholecystectomy. The indication is symptomatic gallstone disease. If the laparoscopic cholecystectomy transfers to an open procedure, the patients will receive an equal follow up (intention-to-treat principle).

Exclusion Criteria

- Patients with cholecystitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer
- Patients with a medical history of epilepsy, cardiac arrhytmias or chronical pain of any kind .
- If a patient is allergic to drugs of the amid type.
- Pregnancy
- Subject suffering from hypotension or hypovolemia.
- Subjects suffering from liver disease
- Subject using drugs which deduce function of the CYP3A4 system like ketoconazol.
-Subject using drugs which deduce function of the CYP1A2 system like the methylxanthines(Fluvoxamin enoxacin)
- Patients with conditions making them incapable of filling out the questionnaires.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative Visual Analogue Score is conducted just before the procedure and<br /><br>afterwards at 30 min, 2h, 4h, 8h, and 24 hours, split in shoulder pain and<br /><br>abdominal pain. The abdominal/shoulder pain scores will also be split in rest,<br /><br>cough and movement pain</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Rescue analgesia treatment. Rescue analgesia will be given when the pain<br /><br>score (VAS) rises above 40.<br /><br>- Adverse events caused by the investigational procedure or by levobupivacaine<br /><br>itself.<br /><br>- Length of the surgical procedure<br /><br>- Length of hospital stay<br /><br>- Time to resumption of work or other usual daily activities<br /><br>- Development of postoperative complications during hospitalisation including<br /><br>pneumonia, thrombosis, urinary tract infections, wound abscess and bile leakage.<br /><br>- Development of intraoperative complications including perforation of the<br /><br>gallbladder, bile duct injury, bowel injury and injury to vascular structures.<br /><br>- The presence of persistent postoperative pain after three<br /><br>months</p><br>