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Phase 3 N=50 Randomized Quadruple-blind Treatment

A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery

Postoperative Pain · Postoperative Nausea and Vomiting

Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Mar 2017
Primary outcome: Primary: Prevalence of Postoperative Gut Dysfunction — 13; 15 Participants — p=0.264

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Targinact (Drug); Oxycodone (Drug); Laparoscopic segmental colectomy (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Edinburgh
Primary completion
Aug 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Prevalence of Postoperative Gut Dysfunction
13; 15 0.264
SECONDARY
Total Opioid Analgesia Consumption
78; 94 0.222
SECONDARY
Pain Scores
2; 2 0.676

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).

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for elective laparoscopic segmental colectomy at the Colorectal Surgery Unit, Western General Hospital, Edinburgh.

Exclusion Criteria

  • Pregnancy Age <18 years Patients lacking capacity to give informed consent. Severe liver dysfunction (Child's A or greater) Patients participating in another therapeutic clinical trial Contraindication to oxycodone, naloxone or Targinact Pre-existing dependence on opioid analgesia (current medications will be checked prior to discussing consent) Pre-existing use of opioid analgesia for chronic pain (current medications will be checked prior to discussing consent) Patients with rectal cancer Plan to form any stoma during procedure
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02109640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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