Postoperative Pain Management Clinical Trial
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
Verified date | March 2017 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 90 |
Est. completion date | February 28, 2017 |
Est. primary completion date | February 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep of Urology Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of stay of the epidural catheter in days | At removal of the catheter, expected to be on average of 6 days | ||
Secondary | Pain scores (NRS 0-10) at postoperative day (POD) 1 to POD 7 | Measured in numeric rating score NRS; measured by questionnaire | From postoperative day (POD) 1 to 7 | |
Secondary | Duration of the return of the bowel function in days | From postoperative day (POD) 1 to 7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01736358 -
The Use of Intranasal Ketoralac for Pain Management (Sprix)
|
Phase 4 | |
Completed |
NCT00806806 -
Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT02143141 -
Low Pain Prediction in Cesarean Section Patients
|
Phase 4 | |
Recruiting |
NCT05011084 -
Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery
|
N/A | |
Terminated |
NCT03428984 -
Study in Adult Subjects Undergoing Posterolateral Thoracotomy
|
Phase 1 | |
Completed |
NCT04371341 -
A Comparative Study Between Different Volumes During Erector Spinae Block for Pain Control
|
N/A | |
Recruiting |
NCT06298370 -
The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty
|
N/A | |
Completed |
NCT06028061 -
Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant
|
N/A | |
Completed |
NCT05401916 -
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery
|
N/A | |
Terminated |
NCT03927911 -
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
|
Phase 4 | |
Completed |
NCT01344213 -
Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
|
Phase 4 | |
Completed |
NCT04434339 -
Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery
|
N/A | |
Recruiting |
NCT02997215 -
Intravenous Lidocaine and Postoperative Pain Management
|
Phase 4 | |
Completed |
NCT01070108 -
Escalating Ketamine Doses and Pre-emption
|
N/A | |
Not yet recruiting |
NCT06148168 -
Magnesium Sulphate in Oblique Subcostal TAP Block
|
Phase 2/Phase 3 | |
Terminated |
NCT03015961 -
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
|
Phase 4 | |
Completed |
NCT01726686 -
Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump
|
Phase 4 | |
Not yet recruiting |
NCT04525963 -
The Effect of Operating Room Nurse Visit Prior to Cardiac Surgery on Patients's Anxiety, Pain and Analgesic Use
|
N/A | |
Completed |
NCT03437707 -
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery
|
N/A | |
Completed |
NCT04691856 -
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy
|
N/A |