Pain Reduction After Cholecystectomy

Phase 4

Completed

• Conditions: Cholecystolithiasis; Postoperative Pain
• Interventions: Drug: Levobupivacaine

• Registration Number: NCT01199406
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Study First Posted: 2010-09-13
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine	Levobupivacaine	80mL 0.125% levobupivacaine
normal saline	Levobupivacaine	80 mL 0.9% NaCl

Primary Outcome Measures

Name	Time	Method
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)	24 h postoperatively	Postoperative abdominal pain

Secondary Outcome Measures

Name	Time	Method
Shoulder pain	24 h	Postoperative shoulder pain
Rescue Analgesics	24 h postoperatively	The need of rescue analgesics within the 24h postoperatively
adverse events caused by the investigational procedure or by levobupivacaine itself	Intra- and postoperative up to 24 hours	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	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)	Infection, bleeding, embolisation etc.

Trial Locations

Locations (1)

Meander MC; 🇳🇱 Amersfoort, Netherlands