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Clinical Trials/NL-OMON33385
NL-OMON33385
Recruiting
Phase 3

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

Meander Medisch Centrum0 sites80 target enrollmentTBD
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Conditionsgallstonessymptomatic gallstone disease10017943

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
gallstones
Sponsor
Meander Medisch Centrum
Enrollment
80
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Meander Medisch Centrum

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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