Epidural Clonidine for Postoperative Hyperalgesia

• Status: Withdrawn
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We propose performing a study in which we compare the effects of bupivacaine and fentanyl with a different drug combination - bupivacaine and clonidine. The principal research questions of the study are:

1. To compare the effect of clonidine (with bupivacaine), injected into the epidural space on the extent of hyperalgesia (abnormal pain/sensitivity in the uninjured skin surrounding the operation site) in patients undergoing operations for bowel disease, with that of fentanyl (with bupivacaine).

2. To compare the effect of clonidine (with bupivacaine), injected into the epidural space on the incidence of chronic pain 6 months after surgery for bowel disease, with that of fentanyl (with bupivacaine).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Clonidine

Criteria

Inclusion Criteria:

1. Age 18-80 years

2. Scheduled for elective major bowel surgery through a vertical midline incision

3. An epidural catheter for pain relief during and after the operation is required and the patient has already consented to it.

4. Good physical health or if they have any disease (e.g. heart disease, high blood pressure, asthma), it should be well controlled with medication.

Exclusion Criteria:

1. Previous abdominal surgery, kidney or liver disease

2. Inability to understand or comply with the study protocol

3. Allergy to any of the study drugs

4. Failure of either placement of an epidural catheter or poor pain relief with epidural analgesia.