A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Two key requirements for discharge from hospital after major abdominal surgery are adequate
oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed
discharge after abdominal surgery due to delayed return of gut function, manifesting as
nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are
the mainstay of postoperative analgesic regimens after abdominal surgery and are highly
effective in achieving adequate pain control. However, opioids cause impaired gut function by
reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as
Alvimopan counteract these effects and can accelerate postoperative gut recovery but are
expensive and cause cardiac complications; alternative painkillers such as non-steroidal
anti-inflammatories are less effective than opioids and have been linked with increased risk
of anastomotic leaks.
Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride)
and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product
confines the naloxone action to the gut to reduce the unwanted side-effects on gut function.
Targinact has been shown in patients with chronic severe pain to provide comparable analgesia
to other opioid analgesics whilst reducing the unwanted side-effect of constipation.
The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia
after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical
procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently
reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective
data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of
normal gut function at the time of planned discharge (Day 3).