A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery
Condition: Postoperative Pain; Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: Targinact; Oxycodone; Laparoscopic segmental colectomy
Intervention description: Post-operative analgesia; Postoperative analgesia
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal; Surgery; Laparoscopic; Analgesia; Enhanced Recovery; Targinact

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