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

NCT05662566 | Completed

• 1 other identifier: WZ22042433
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Postoperative Pain; Central Sensitisation

Keywords

Failed epidural; Chronic pain syndrome; Central Sensitization; Opioid use; Opioid Naive

Outcome Measures

Primary Outcomes (1)

• Epidural replacement

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

  5 days postoperative

Secondary Outcomes (3)

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

  Total time of hospital stay up to 52 weeks

• postoperative epidural optmisation

  5 days postoperative

• Number of epidural replacements

  5 days postoperative

Study Arms (2)

Chronic pain

Patients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy

Procedure: Epidural replacement

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

Procedure: Epidural replacement

Interventions

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

Chronic pain; No chronic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Eske Kvanner Aasvang: lead

Study Sites (1)

Eske Kvanner Aasvang [eaasvang]

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSci

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 22, 2022
• Study Start: March 17, 2023
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)