Epidural Clonidine for Postoperative Hyperalgesia

NCT00417443 | Withdrawn Phase 3

• 1 other identifier: EPICLO2006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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).

Conditions

Postoperative Hyperalgesia

Keywords

epidural; clonidine; hyperalgesia; laparotomy

Outcome Measures

Primary Outcomes (2)

• Extent of peri-incisional hyperalgesia in patients undergoing laparotomy for bowel disease

• Incidence of chronic pain 6 months after laparotomy for bowel disease

Interventions

Clonidine DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Scheduled for elective major bowel surgery through a vertical midline incision
• An epidural catheter for pain relief during and after the operation is required and the patient has already consented to it.
• Good physical health or if they have any disease (e.g. heart disease, high blood pressure, asthma), it should be well controlled with medication.

You may not qualify if:

• Previous abdominal surgery, kidney or liver disease
• Inability to understand or comply with the study protocol
• Allergy to any of the study drugs
• Failure of either placement of an epidural catheter or poor pain relief with epidural analgesia.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB1 9YJ, United Kingdom

Location

MeSH Terms

Conditions

Hyperalgesia

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anthony Absalom, MBBS MD FRCA

  Addenbrooke's NHS Trust, Cambridge, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: January 1, 2007
• Study Start: December 1, 2007
• Study Completion: December 1, 2009
• Last Updated: January 8, 2014

Record last verified: 2006-12

Locations

GB (1)