Clinical trial NCT05662566: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use
Official title: Cohort Study: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use Undergoing Laparotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Postoperative Pain
Central Sensitisation
Keywords: Failed epidural
Chronic pain syndrome
Central Sensitization
Opioid use
Opioid Naive
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with or without chronic pain and opioid use undergoing elective laparotomi with epidural anesthesia as a part of the postoperative pain treatment.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparotomy with epidural anesthesia as a part of the postoperative pain treatment
* 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:

* Patients with substance abuse
* Suspected withdrawal due to opioid deficiency - noted in the medical chart

Primary outcomes:
measure: Epidural replacement
timeFrame: 5 days postoperative
Secondary outcomes:
measure: Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital
timeFrame: Total time of hospital stay up to 52 weeks
measure: postoperative epidural optmisation
timeFrame: 5 days postoperative
measure: Number of epidural replacements
timeFrame: 5 days postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Eske Kvanner Aasvang [eaasvang]
Study officials:
References: