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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02109640
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
University of Edinburgh

Brief 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).

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Drug: Targinact Drug: Oxycodone Procedure: Laparoscopic segmental colectomy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery
Study Start Date : October 2014
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Targinact
Oral Targinact 10-20mg bd following laparoscopic segmental colectomy
Drug: Targinact
Post-operative analgesia
Other Name: Oxycodone-Naloxone
Procedure: Laparoscopic segmental colectomy
Active Comparator: Oxycodone
Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy
Drug: Oxycodone
Postoperative analgesia
Procedure: Laparoscopic segmental colectomy

Primary Outcome Measures :
  1. Prevalence of Postoperative Gut Dysfunction [ Time Frame: Day 3 post-op ]
    The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.

Secondary Outcome Measures :
  1. Total Opioid Analgesia Consumption [ Time Frame: Total postoperative period of analgesic consumption, an average of 1 week ]
    Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant

  2. Pain Scores [ Time Frame: Postoperative day 3 ]

    Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:

    • Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain
    • Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)
    • Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)
    • Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)
    • Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)
    • Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)
    • How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511-18 (2010)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02109640

United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Sponsors and Collaborators
University of Edinburgh
Principal Investigator: Hugh M Paterson, MD FRCS University of Edinburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Edinburgh Identifier: NCT02109640     History of Changes
Other Study ID Numbers: 2013-005327-16
First Posted: April 10, 2014    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Edinburgh:
Enhanced Recovery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Nausea and Vomiting
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists