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Early Postoperative Administration of Oxycodone +/- Naloxone and Duration of Epidural Analgesia

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ClinicalTrials.gov Identifier: NCT02516059
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

Cystectomy with urinary diversion (ileal conduit, ileal orthotopic neobladder, catheterizable ileal pouch) is major abdominal surgery, which is associated with a high incidence of gastrointestinal complications.Perioperative techniques aiming at an early return of bowel function are to be pursued.

Optimal postoperative pain management is one of the key factors leading to enhanced recovery after surgery. The perioperative use of an epidural analgesia for major abdominal surgery is established, not only because of its excellent analgesic properties, but also because it can accelerate the return of bowel function. However, epidural analgesia is associated with additional costs, need for close monitoring and nursing. In addition each supplemental day with an indwelling epidural catheter increases the risk of infection. So it is recommended to re-assess the risk/benefit ratio of an epidural analgesia after 4 days, if not sooner. Therefore, it is important to develop strategies that reduce its duration without impairing the benefits. Systemic analgesics with prolonged-release oral formulation like oral oxycodone (Oxycontin®) or combined drug mixture (oral oxycodone/naloxone (Targin®)) could be a valuable alternative pain treatment as a second analgesic step, starting on postoperative day (POD) 3, so that the epidural catheter could be removed earlier without impairing postoperative enhanced recovery including return of the bowel function. Both oxycodone and naloxone orally administered are a recognized and accepted treatment option.

The objective of this study is to evaluate the implementation of an oral opioid with or without naloxone in the early postoperative period in patients undergoing open radical cystectomy with urinary diversion and intraoperative and early postoperative use of epidural analgesia. The investigators expect an unchanged early return of the bowel function and equal analgesia with a reduced length of stay of the epidural catheter (primary endpoint), thus potentially reducing epidural catheter associated complications and lowering costs (nursing and pain service).


Condition or disease Intervention/treatment Phase
Postoperative Pain Management Radical Cystectomy Epidural Analgesia Oral Oxycodone With/Without Naloxone Return of the Bowel Function Drug: oxycodone/naloxone Drug: Oxycodone Drug: Placebo Device: epidural catheter Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Postoperative Administration of Oral Oxycodone With/Without Naloxone, Reduce the Duration of Epidural Analgesia in Patients Undergoing Cystectomy Without Impairing Its Benefits? A Randomized, Double Blind Controlled Trial
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : February 28, 2017


Arm Intervention/treatment
Active Comparator: Oxycodone and naloxone (Targin®)
Oxycodone and naloxone (Targin®; Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10mg/5mg on POD 3 and move to 20mg/10mg the other day.
Drug: oxycodone/naloxone
Oxycodone and naloxone (Targin®; Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10mg/5mg on POD 3 and move to 20mg/10mg the other day.
Other Name: Targin®

Device: epidural catheter
Active Comparator: Oxycodone (Oxycontin®)
Oxycodone (Oxycontin®, Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10 mg on POD 3 and move to 20 mg the other day.
Drug: Oxycodone
Oxycodone (Oxycontin®, Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10 mg on POD 3 and move to 20 mg the other day.
Other Name: Oxycontin®

Device: epidural catheter
Placebo Comparator: Placebo
Placebo (Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals starting on POD 3.
Drug: Placebo
Placebo (Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals starting on POD 3.

Device: epidural catheter



Primary Outcome Measures :
  1. Length of stay of the epidural catheter in days [ Time Frame: At removal of the catheter, expected to be on average of 6 days ]

Secondary Outcome Measures :
  1. Pain scores (NRS 0-10) at postoperative day (POD) 1 to POD 7 [ Time Frame: From postoperative day (POD) 1 to 7 ]
    Measured in numeric rating score NRS; measured by questionnaire

  2. Duration of the return of the bowel function in days [ Time Frame: From postoperative day (POD) 1 to 7 ]


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

Inclusion Criteria:

  • At least 18 years old
  • Informed Consent as documented by signature
  • Renal function: eGFR >40ml/min
  • Normal liver function
  • Cystectomy with urinary diversion
  • Use of thoracic epidural analgesia

Exclusion Criteria

  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, i.e. known allergy to oxycodone naloxone or other excipients
  • Women who are pregnant or breast feeding, (exclusion for surgery per se)
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, severe psychiatric disorder, etc. of the participant
  • Severe asthma bronchiale, severe COPD
  • Severe respiratory depression with hypoxia and/or hypercapnoea, cor pulmonale
  • Preoperative use of MAO-Inhibitors (or has to be stopped 2 weeks before surgery)
  • Patients with chronic pain
  • Patients with regular use of antiemetics, laxatives, opioids or other types of analgesics
  • Preoperative regular use of non steroidal anti inflammatory drugs and steroids

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 ClinicalTrials.gov identifier (NCT number): NCT02516059


Locations
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Switzerland
Dep of Urology Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Patrick Y Wuethrich, MD Department of Anaesthesiology and Pain Therapy, University Hospital Bern
Study Director: Fiona C Burkhard, MD Department of Urology, University Hospital Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02516059     History of Changes
Other Study ID Numbers: 068/15
WUPD 01-14 ( Other Identifier: Inselspital )
2015DR4112 ( Other Identifier: Swissmedic )
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Keywords provided by University Hospital Inselspital, Berne:
thoracic epidural analgesia
oxycodone
oral naloxone
radical cystectomy
bowel function
pain

Additional relevant MeSH terms:
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Oxycodone
Agnosia
Pain, Postoperative
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists