An observational study in Chronic Pain, Postoperative Pain and Central Sensitisation, sponsored by Eske Kvanner Aasvang. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Eske Kvanner Aasvang · Observational
Patients with chronic pain syndrome (CPS) may develop central sensitization wich may lead to increased pain intensity and lower pain threshold sometimes to the extend of hyperalgesia and allodynia. Furthermore, patients with daily use of opioids may develop opioid tolerance, and to a lesser extent opioid induced hyperalgesia.
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.
Adult patients with or without chronic pain and opioid use undergoing elective laparotomi with epidural anesthesia as a part of the postoperative pain treatment.
Exclusion Criteria:
Patients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy
Procedure: Epidural replacement
Patients without chronic pain and without fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy
Procedure: 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
Epidural replacement
Number of patients with the need of a new insertion of the epidural catheter
Time frame: 5 days postoperative
Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital
Length of stay at post anaesthetic care unit / the surgical ward / entire admission. Defined from admission until discharged from the specific unit.
Time frame: Total time of hospital stay up to 52 weeks
postoperative epidural optmisation
Return to the post anaesthetic care unit for epidural optimisation with medicine titration or retraction of the epidural catheter
Time frame: 5 days postoperative
Number of epidural replacements
Number of epidural replacements per patient
Time frame: 5 days postoperative
Plan to share: No
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Eske Kvanner Aasvang