Epidural Analgesia After Major Open Abdominal SurgeryPAPCAMNCT04912557
Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery
An observational study of Epidural Analgesia After Major Open Abdominal Surgery, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Analgesia After Major Open Abdominal Surgery
- What is being tested?
- postoperative pain assess
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2021to 11 Dec 2021
- 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: all patients with major abdominal surgery operated by laparotomy
Who may be able to join
- Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
- epidural analgesia accepted
Who cannot join
- Minor or protected patient
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breastfeeding woman
- Contraindication or refusal of epidural analgesia
- Failure of the initial placement of the epidural catheter
- Major intraoperative complication requiring continued postoperative sedation
Trial locations and contacts
1 site in 1 country.
About this study
Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.
Read the detailed description
Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.
Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.
In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.
- Being tested
- postoperative pain assess
- Keywords
- epidural analgesia, open abdominal surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative pain assessOther
Also called numerical pain scale
numerical pain scale and Metameric levels of cold insensitivity
| Study group | Role | What they receive |
|---|---|---|
| Patients | Open major abdominal surgery patient (predicted operative time ≥ 2 hours) with Peridural Analgesia accepted Receives: Other: postoperative pain assess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insufficient epidural analgesia
Insufficient epidural analgesia will be defined by the presence of pain assessed by numerical scale > 3/10 at rest OR on coughing OR on mobilization.
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start14 Jun 2021
- Primary completion11 Dec 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Analgesia After Major Open Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume PORTA-BONETE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912557
- Sponsor's protocol ID
- RC31/21/0160
- Other IDs
- 2021-A00926-35
- Acronym
- PAPCAM
- Status last verified
- Sep 2024
- First submitted
- 28 May 2021
- Last updated
- 25 Sep 2024
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04912557
- Acronym / sponsor ID
- PAPCAM / RC31/21/0160
- Keywords
- epidural analgesia, open abdominal surgery, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 3 Jun 2021 (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.
Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.
Detailed description
Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.
Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.
In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: postoperative pain assessOpen major abdominal surgery patient (predicted operative time ≥ 2 hours) with Peridural Analgesia accepted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients with major abdominal surgery operated by laparotomy
Key inclusion criteria (2 listed)
- Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
- epidural analgesia accepted
Key exclusion criteria (6 listed)
- Minor or protected patient
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breastfeeding woman
- Contraindication or refusal of epidural analgesia
- Failure of the initial placement of the epidural catheter
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 |
|---|---|---|
| postoperative pain assessAlso: numerical pain scalenumerical pain scale and Metameric levels of cold insensitivity | Other | Patients |
Primary outcome
Insufficient epidural analgesia
Time frame: day 5
Insufficient epidural analgesia will be defined by the presence of pain assessed by numerical scale > 3/10 at rest OR on coughing OR on mobilization.
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 25 Sep 2024.
- Individual participant dataSharing planned: No
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.
Guillaume PORTA-BONETE, MD principal investigator
University Hospital, Toulouse
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 Epidural Analgesia After Major Open Abdominal Surgery, run by University Hospital, Toulouse at 1 site in France.
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 2 inclusion and 6 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 25 Sep 2024. 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 France. 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?
Insufficient epidural analgesia (time frame: day 5). 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 25 Sep 2024.