Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use
NCT ID: NCT05662566
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
150 participants
OBSERVATIONAL
2023-03-17
2025-04-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
These factors may lead to a higher pain intensity in the perioperative setting resulting in the observed increased opioid dosage needed to treat the acute pain. Furthermore opioid titration may be difficult with higher levels of pain and a higher risk of opioid related adverse effects incl. respiratory depression and sedation.
The factors above advocate for utilizing opioid sparing analgesic techniques. In our department as in many others we use an multimodal opioid sparing approach for surgical procedures including epidural anesthesia (EA) as a standard part of the perioperative analgesia strategy after upper laparotomy, as a sufficient epidural anesthesia has shown to provide a stable and often better pain relief than systemic opioids in these patients.
Clinically, there is a suspicion that patients with CPS on fixed opioid treatment have a higher frequency of need for epidural optimization, despite the lack of an anatomical reason for this. One potential explanation could be an altered nociception, requesting another EA strategy than in non-opioid patients.
Purpose and hypothesis This study will explore the frequency of failed EA, defined as EA with insufficient analgesic effect to the extent were replacements of the epidural is needed within the first 5 postoperative days (PODs), testing the hypothesis that failed epidural occurs more frequent in patients with CPS on fixed opioid treatment than in non-opioid patients without CPS.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
NCT06559969
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
NCT02573922
Transition From Acute to Chronic Opioid Use and Chronic Pain
NCT07211399
Satisfaction Following Cesarean Section
NCT03355248
Collecting Interval Timed Incisional Epidermal and Dermal Tissue Samples During Surgical Procedures to Profile Temporal Response of Tissue After Noxious Stimuli
NCT04224870
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic pain
Patients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy
Epidural replacement
Insufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed.
Defined as insertion of a new epidural catheter
No chronic pain
Patients without chronic pain and without fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy
Epidural replacement
Insufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed.
Defined as insertion of a new epidural catheter
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epidural replacement
Insufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed.
Defined as insertion of a new epidural catheter
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For the intervention group - Patients with chronic pain disorder defined as pain for more than 3 months and a daily use of opioids regardless of dosage.
* For the control group - No chronic pain disorder defined as no daily use of opioid or other medicine with strong analgetic effect. A daily use of Acetaminophen and NSAIDs were deemed acceptable.
Exclusion Criteria
* Suspected withdrawal due to opioid deficiency - noted in the medical chart
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eske Kvanner Aasvang
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eske Kvanner Aasvang
Professor, MD, DMSci
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eske Kvanner Aasvang [eaasvang]
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WZ22042433
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.