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NCT Number: NCT05662566

Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eske Kvanner Aasvang [eaasvang]

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural replacement

Procedure

Insufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed.

Defined as insertion of a new epidural catheter

Primary outcomes

  1. Epidural replacement

    Time frame: 5 days postoperative

    Number of patients with the need of a new insertion of the epidural catheter

Secondary outcomes

  1. Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital

    Time frame: Total time of hospital stay up to 52 weeks

    Length of stay at post anaesthetic care unit / the surgical ward / entire admission. Defined from admission until discharged from the specific unit.

  2. postoperative epidural optmisation

    Time frame: 5 days postoperative

    Return to the post anaesthetic care unit for epidural optimisation with medicine titration or retraction of the epidural catheter

  3. Number of epidural replacements

    Time frame: 5 days postoperative

    Number of epidural replacements per patient

Sponsors and collaborators

Lead sponsor

Eske Kvanner Aasvang

Other

Registry information

Official study title

Cohort Study: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use Undergoing Laparotomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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