Pain Reduction After Cholecystectomy

Postoperative Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199406
• Other study ID #: Intense Trial
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2010
• Last updated: September 10, 2010
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2010
• Source: Meander Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Netherlands	Meander MC	Amersfoort

Sponsors (1)

Lead Sponsor	Collaborator
Meander Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)	Postoperative abdominal pain	24 h postoperatively	No
Secondary	Shoulder pain	Postoperative shoulder pain	24 h	No
Secondary	Rescue Analgesics	The need of rescue analgesics within the 24h postoperatively	24 h postoperatively	No
Secondary	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.	Intra- and postoperative up to 24 hours	Yes
Secondary	Length of hospital stay		Maximum two weeks	No
Secondary	intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures		intraoperative, 1 hour	Yes
Secondary	postoperative complications during hospitalisation	Infection, bleeding, embolisation etc.	during hospitalisation (up to two weeks)	Yes