A study of effect of epidural clonidine on postoperative pain relief, hyperalgesia and chronic pain in patients undergoing colorectal surgery - Epidural clonidine for postoperative analgesia
Phase 1
- Conditions
- 1. Postoperative pain and hyperalgesia following laparotomy for colorectal surgery 2. Chronic pain following laparotomy for colorectal surgery
- Registration Number
- EUCTR2006-004796-35-GB
- Lead Sponsor
- R&D Department, Box 146, Addenbrooke's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients undergoing laparotomy through vertical midline incision for colonic pathology and requiring an epidural catheter for perioperative analgesia, ASA physical status I-III, between 18-80 years of age.
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
Previous abdominal surgery, renal or hepatic dysfunction, inability to understand or comply with the study protocol, allergy to any of the study drugs, impossible to place an epidural catheter, malfunctioning epidural catheter.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of clonidine in reduction in area of hyperalgesia around the incision following laparotomy;Secondary Objective: Efficacy of clonidine in treatment of acute and chronic pain;Primary end point(s): Reduction in area of post-incisional hyperalgesia on the third postoperative day following laparotomy for colorectal surgery.
- Secondary Outcome Measures
Name Time Method