Clinical Trial: Epidural Clonidine for Postoperative Hyperalgesia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Study of Effect of Epidural Clonidine on Postoperative Pain Relief, Hyperalgesia and Chronic Pain in Patients Undergoing Colorectal Surgery

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. 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).

Detailed Summary:

In addition to pain at the surgical incision site, patients undergoing major bowel operations commonly experience pain in the surrounding (uninjured)skin during the postoperative period − this phenomenon is known as hyperalgesia. In most patients hyperalgesia resolves with healing of the wound, but in some patients it persists. Recent studies have shown that 25% of patients undergoing bowel surgery will have chronic pain at 1 year following surgery. This pain can be debilitating and has significant implications, both for the individual and for society. For the individual there are significant physical, mental, social and economic implications. The burden on society is significant because bowel surgery operations are very common, and many of the 25% of the patients who develop chronic pain will required ongoing treatment and unable to work.Chronic pain after surgery is believed to be a result of changes in the central nervous system (i.e. brain and spinal cord)occurring during and immediately after the surgery. Indeed the likelihood of a patient developing chronic pain is related to the extent of hyperalgesia during the initial post−operative period. Two other important predisposing factors are the emotional state of the patient and the genetic predisposition of the patient to develop chronic pain states. In our hospital, in common with most western hospitals, patients undergoing major bowel surgery commonly have an epidural catheter (a soft plastic tube inserted in the space surrounding the spinal cord fluid) inserted before the operation to facilitate the administration, during the first few postoperative days, of a combination of a local anaesthetic agent (bupivacaine in our hospital) and an opiate drug (a morphine−like medicine; fentanyl is used in our hospital). Unfortunately, neither fentanyl nor bupivacaine appear to reduce the incidence of hyperalgesia. In fact there is evidence that larger doses
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome:

  • Extent of peri-incisional hyperalgesia in patients undergoing laparotomy for bowel disease
  • Incidence of chronic pain 6 months after laparotomy for bowel disease


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: December 28, 2006
Date Started: December 2007
Date Completion: December 2009
Last Updated: January 7, 2014
Last Verified: December 2006