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

NCT02516059 | Completed Phase 4

• 3 other identifiers: 068/15WUPD 01-142015DR4112
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Pain Management; Radical Cystectomy; Epidural Analgesia; Oral Oxycodone With/Without Naloxone; Return of the Bowel Function

Keywords

thoracic epidural analgesia; oxycodone; oral naloxone; radical cystectomy; bowel function; pain

Outcome Measures

Primary Outcomes (1)

• Length of stay of the epidural catheter in days

  At removal of the catheter, expected to be on average of 6 days

Secondary Outcomes (2)

• Pain scores (NRS 0-10) at postoperative day (POD) 1 to POD 7

  From postoperative day (POD) 1 to 7

• Duration of the return of the bowel function in days

  From postoperative day (POD) 1 to 7

Study Arms (3)

Oxycodone and naloxone (Targin®)

ACTIVE COMPARATOR

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; Device: epidural catheter

Oxycodone (Oxycontin®)

ACTIVE COMPARATOR

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; Device: epidural catheter

Placebo

PLACEBO COMPARATOR

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; Device: epidural catheter

Interventions

oxycodone/naloxone DRUG

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.

Also known as: Targin®

Oxycodone and naloxone (Targin®)

Oxycodone DRUG

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.

Also known as: Oxycontin®

Oxycodone (Oxycontin®)

Placebo DRUG

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

Placebo

epidural catheter DEVICE

Oxycodone (Oxycontin®); Oxycodone and naloxone (Targin®); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep of Urology Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pain

Interventions

Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Patrick Y Wuethrich, MD

  Department of Anaesthesiology and Pain Therapy, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Fiona C Burkhard, MD

  Department of Urology, University Hospital Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: September 14, 2015
• Primary Completion: February 20, 2017
• Study Completion: February 28, 2017
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

CH (1)