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Pain Reduction After Cholecystectomy (INTENSE)

Primary Purpose

Cholecystolithiasis, Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Levobupivacaine

About this trial

This is an interventional treatment trial for Cholecystolithiasis focused on measuring gallstone, gallbladder, cholecystectomy, laparoscopic, pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Meander MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

normal saline

Levobupivacaine

Arm Description

80 mL 0.9% NaCl

80mL 0.125% levobupivacaine

Outcomes

Primary Outcome Measures

Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)

Postoperative abdominal pain

Secondary Outcome Measures

Shoulder pain

Postoperative shoulder pain

Rescue Analgesics

The need of rescue analgesics within the 24h postoperatively

adverse events caused by the investigational procedure or by levobupivacaine itself

Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered.

Length of hospital stay

intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures

postoperative complications during hospitalisation

Infection, bleeding, embolisation etc.

Full Information

NCT ID

NCT01199406

First Posted

September 9, 2010

Last Updated

September 10, 2010

Sponsor

Meander Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01199406

Brief Title

Pain Reduction After Cholecystectomy

Acronym

INTENSE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Meander Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystolithiasis, Postoperative Pain

Keywords

gallstone, gallbladder, cholecystectomy, laparoscopic, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

normal saline

Arm Type

Placebo Comparator

Arm Description

80 mL 0.9% NaCl

Arm Title

Levobupivacaine

Arm Type

Experimental

Arm Description

80mL 0.125% levobupivacaine

Intervention Type

Drug

Intervention Name(s)

Levobupivacaine

Other Intervention Name(s)

Chirocaine (brand name), NDA 20-997

Intervention Description

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

Primary Outcome Measure Information:

Title

Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)

Description

Postoperative abdominal pain

Time Frame

24 h postoperatively

Secondary Outcome Measure Information:

Title

Shoulder pain

Description

Postoperative shoulder pain

Time Frame

24 h

Title

Rescue Analgesics

Description

The need of rescue analgesics within the 24h postoperatively

Time Frame

24 h postoperatively

Title

adverse events caused by the investigational procedure or by levobupivacaine itself

Description

Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered.

Time Frame

Intra- and postoperative up to 24 hours

Title

Length of hospital stay

Time Frame

Maximum two weeks

Title

intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures

Time Frame

intraoperative, 1 hour

Title

postoperative complications during hospitalisation

Description

Infection, bleeding, embolisation etc.

Time Frame

during hospitalisation (up to two weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: