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

Completed

• Conditions: Postoperative Pain; Chronic Pain; Central Sensitisation
• Interventions: Procedure: Epidural replacement

• Registration Number: NCT05662566
• Lead Sponsor: Eske Kvanner Aasvang

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Study Start: 2023-03-17
• Status Verified: 2025-04
• Primary Completion: 2025-04-02
• Study Completion: 2025-04-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic pain	Epidural replacement	Patients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy
No chronic pain	Epidural replacement	Patients without chronic pain and without fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy

Primary Outcome Measures

Name	Time	Method
Epidural replacement	5 days postoperative	Number of patients with the need of a new insertion of the epidural catheter

Secondary Outcome Measures

Name	Time	Method
Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital	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.
postoperative epidural optmisation	5 days postoperative	Return to the post anaesthetic care unit for epidural optimisation with medicine titration or retraction of the epidural catheter
Number of epidural replacements	5 days postoperative	Number of epidural replacements per patient

Trial Locations

Locations (1)

Eske Kvanner Aasvang [eaasvang]; 🇩🇰 Copenhagen, Denmark