Pain Reduction After Cholecystectomy

Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial

Sponsors

Lead Sponsor: Meander Medical Center

Source Meander Medical Center
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date 2009-07-01
Completion Date 2010-01-01
Primary Completion Date 2010-01-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) 24 h postoperatively
Secondary Outcome
Measure Time Frame
Shoulder pain 24 h
Rescue Analgesics 24 h postoperatively
adverse events caused by the investigational procedure or by levobupivacaine itself Intra- and postoperative up to 24 hours
Length of hospital stay Maximum two weeks
intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures intraoperative, 1 hour
postoperative complications during hospitalisation during hospitalisation (up to two weeks)
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Levobupivacaine

Description: 0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Location
Facility: Meander MC
Location Countries

Netherlands

Verification Date

2010-09-01

Responsible Party

Name Title: dr. Consten

Organization: Meander medical Center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: normal saline

Type: Placebo Comparator

Description: 80 mL 0.9% NaCl

Label: Levobupivacaine

Type: Experimental

Description: 80mL 0.125% levobupivacaine

Acronym INTENSE
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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