Chronic PainNCT05662566
Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use
An observational study of Chronic Pain and Postoperative Pain, run by Eske Kvanner Aasvang at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Postoperative Pain, Central Sensitisation
- What is being tested?
- Epidural replacement
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2023to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with substance abuse
- Suspected withdrawal due to opioid deficiency - noted in the medical chart
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort Study: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use Undergoing Laparotomy
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.
Read more
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
- Being tested
- Epidural replacement
- Keywords
- Failed epidural, Chronic pain syndrome, Central Sensitization, Opioid use, Opioid Naive
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural replacementProcedure or surgery
Insufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed.
Defined as insertion of a new epidural catheter
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain | Patients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy Receives: 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 Receives: Procedure: Epidural replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural replacement
Number of patients with the need of a new insertion of the epidural catheter
Measured: 5 days postoperative
Secondary outcomes (3)
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.
Measured: 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
Measured: 5 days postoperative
Number of epidural replacements
Number of epidural replacements per patient
Measured: 5 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start17 Mar 2023
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662566
- Sponsor's protocol ID
- WZ22042433
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study: Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use Undergoing Laparotomy
- ClinicalTrials.gov ID
- NCT05662566
- Acronym / sponsor ID
- WZ22042433
- Conditions
- Chronic Pain, Postoperative Pain, Central Sensitisation
- Keywords
- Failed epidural, Chronic pain syndrome, Central Sensitization, Opioid use, Opioid Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic pain | – | Procedure: Epidural replacementPatients with chronic pain and fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy |
| No chronic pain | – | Procedure: Epidural replacementPatients without chronic pain and without fixed opioid use, undergoing laparotomy with epidural anesthesia as a part of the postoperative analgesic strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with substance abuse
- Suspected withdrawal due to opioid deficiency - noted in the medical chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural replacementInsufficient analgesic effect of epidural anesthesia to the extent were replacement of the catheter is needed. Defined as insertion of a new epidural catheter | Procedure or surgery | Chronic pain, No chronic pain |
Primary outcome
Epidural replacement
Time frame: 5 days postoperative
Number of patients with the need of a new insertion of the epidural catheter
3 secondary outcomes
Length of stay at the - post anaesthetic care unit (PACU) / Ward / Hospital
Time frame: Total time of hospital stay up to 52 weeks
postoperative epidural optmisation
Time frame: 5 days postoperative
Number of epidural replacements
Time frame: 5 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Postoperative Pain, run by Eske Kvanner Aasvang at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural replacement (time frame: 5 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.