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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006444-63-SE
Enrollment
20
Registered
2007-04-18
Start date
2007-06-14
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Catapressan Product Name: Catapressan Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Injection* Route of administration of the placebo: Parenteral use (Noncurrent) Tr

Sponsors

VO Anesthesia/ICU Lunds University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026