The addition of clonidine to bupivacaine/adrenaline intercostal nerve blockades in patients undergoing open cholecystectomies - Intercostal clonidine

• Conditions: duration and quality of postoperative pain control with intercostal nerve blockade after open cholecystectomies

• Registration Number: EUCTR2006-006444-63-SE
• Lead Sponsor: VO Anesthesia/ICU Lunds University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

·Patients with the diagnosis of cholelithiasis.

·Patients fulfilling criteria for ASA (American Society of Anesthesiologists) classification 1-3; see appendix

·Patients scheduled for either open cholecystectomies or reversed from laparoscopic to open cholecystectomies.

·Signed informed consent by patient.

·Age 18-75 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Preoperative exclusion criteria:

·Chronic pain or ingestion of pain modulating drugs on a regular basis preoperatively.

·Pregnancy

·Non-tolerance or contraindications to local anesthetics, clonidin, adrenalin or opioids.

·Cognitive or linguistic problems precluding effective postoperative pain evaluation.

·Patients with a body weight less than 50 kg or exceeding > 150 kg.

·Dermatitis or infection overlying injection sites or anatomical reason contraindicating an intercostal blockade.

·Chronic Obstructive Pulmonary Disease or other criteria which increase the risk of significant pneumothorax after intercostal blockade.

Intraoperative exclusion criterias:

·Planned laparoscopic surgery completed without conversion to open cholecystectomi.

·Unforeseen complication of anesthetic management requiring prolonged intubation postoperatively.

·Surgical complication with surgical time of > 2 hours, injuries to choledochus or spleen intraoperatively.

·The need for intraabdominal or intrathoracal drainage postoperatively.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate quality and duration of intercostal nerve blockades with the addition of clonidin to the standard infiltration with marcain/adrenalin.;Secondary Objective: patient satisfaction, complications;Primary end point(s): Time to first analgesic injection and opioid consumption postoperatively.