Pain Reduction After Cholecystectomy (INTENSE)

Meander Medical Center

Status and phase

Completed

Phase 4

Conditions

Postoperative Pain

Cholecystolithiasis

Treatments

Drug: Levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01199406

Intense Trial

Details and patient eligibility

About

To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.

Full description

The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

between 18 and 80
ASA I or II
with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy

Exclusion criteria

acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
pregnancy
patients suffering from hypotension or hypovolemia
infectious liver disease
conditions obstructing adequate pain scoring
patients using drugs that deduce function of the CYP3A4 or CYP1A2 system
patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.