Pain Reduction After Cholecystectomy (INTENSE)

M

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.

Trial design

80 participants in 2 patient groups, including a placebo group

normal saline
Placebo Comparator group
Description:
80 mL 0.9% NaCl
Treatment:
Drug: Levobupivacaine
Levobupivacaine
Experimental group
Description:
80mL 0.125% levobupivacaine
Treatment:
Drug: Levobupivacaine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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