Extended Ileal Resection Under LaparotomyPhase 4PERIDIGENCT01470846
Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study
A Phase 4 study testing epidural analgesia and PCA in people with Extended Ileal Resection Under Laparotomy and Total Proctocolectomy Under Laparotomy, run by University Hospital, Limoges at 1 site in France.
Trial summary
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extended Ileal Resection Under Laparotomy, Total Proctocolectomy Under Laparotomy, Colectomy Left/Right/Total Under Laparotomy
- What is being tested?
- epidural analgesia and PCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Apr 2013
- Phase
- Phase 4
- 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
Who may be able to join
- Surgery scheduled under laparotomy
- Extended ileal resection
- Total proctocolectomy
- Colectomy left/right/total
- Rectosigmoidal resection
- Anterior resection of rectum
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- Abdomino-perineal amputation
- Adult patient
- Written consent obtained
- Planned hospitalization in the intensive care unit
- Patient affiliated to social security
Who cannot join
- Patients inapt to give consent
- Emergency surgery
- Contraindication to epidural analgesia
- Contraindication to levobupivacaïne, morphine or sufentanil
- Dementia
- Participation in another research protocol
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.
Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.
Read the detailed description
There are currently two methods of analgesia in postoperative abdominal surgery : patient-controlled analgesia (PCA) with opioids and epidural analgesia.
No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.
- Conditions
- Extended Ileal Resection Under Laparotomy, Total Proctocolectomy Under Laparotomy, Colectomy Left/Right/Total Under Laparotomy, Rectosigmoidal Resection Under Laparotomy, Anterior Resection of Rectum Under Laparotomy, Abdomino-perineal Amputation Under Laparotomy
- Being tested
- epidural analgesia, PCA
- Keywords
- epidural analgesia, morphin analgesia, laparotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural analgesiaProcedure or surgery
thoracic position (T8-T9 or T11-T12) depending on the site of surgery
PCAProcedure or surgery
Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.
| Study group | Role | What they receive |
|---|---|---|
| APD | Experimental | patient with epidural analgesia Receives: Procedure: epidural analgesia |
| PCA | Active comparator | Patient with morphine analgesia Receives: Procedure: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theoretical duration of hospitalization in intensive care unit.
The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.
Measured: 5 days
Secondary outcomes (1)
Total duration of hospitalization.
The difference between the day of surgery and the day when the discharge criteria are met
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2013
- Study completionApr 2013
Why it stopped: Lack of patients eligible for the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extended Ileal Resection Under LaparotomyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie NATHAN-DENIZOT, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470846
- Sponsor's protocol ID
- I10030 PERIDIGE
- Acronym
- PERIDIGE
- Status last verified
- Aug 2014
- First submitted
- 8 Nov 2011
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study
- ClinicalTrials.gov ID
- NCT01470846
- Acronym / sponsor ID
- PERIDIGE / I10030 PERIDIGE
- Conditions
- Extended Ileal Resection Under Laparotomy, Total Proctocolectomy Under Laparotomy, Colectomy Left/Right/Total Under Laparotomy, Rectosigmoidal Resection Under Laparotomy, Anterior Resection of Rectum Under Laparotomy, Abdomino-perineal Amputation Under Laparotomy
- Keywords
- epidural analgesia, morphin analgesia, laparotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients eligible for the study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Nov 2011 (estimated)
- 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.
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.
Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.
Detailed description
There are currently two methods of analgesia in postoperative abdominal surgery : patient-controlled analgesia (PCA) with opioids and epidural analgesia.
No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APD | Experimental | Procedure: epidural analgesiapatient with epidural analgesia |
| PCA | Active comparator | Procedure: PCAPatient with morphine analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Surgery scheduled under laparotomy
- Extended ileal resection
- Total proctocolectomy
- Colectomy left/right/total
- Rectosigmoidal resection
Key exclusion criteria (7 listed)
- Patients inapt to give consent
- Emergency surgery
- Contraindication to epidural analgesia
- Contraindication to levobupivacaïne, morphine or sufentanil
- Dementia
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 analgesiathoracic position (T8-T9 or T11-T12) depending on the site of surgery | Procedure or surgery | APD |
| PCAMorphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL. | Procedure or surgery | PCA |
Primary outcome
Theoretical duration of hospitalization in intensive care unit.
Time frame: 5 days
The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.
1 secondary outcome
Total duration of hospitalization.
Time frame: 9 days
Results and safety
The study was stopped early (reason given: Lack of patients eligible for the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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.
Nathalie NATHAN-DENIZOT, MD principal investigator
Limoges UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epidural analgesia and PCA in people with Extended Ileal Resection Under Laparotomy and Total Proctocolectomy Under Laparotomy, run by University Hospital, Limoges 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Aug 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of patients eligible for the study). Results are not available in the source record.
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?
Theoretical duration of hospitalization in intensive care unit. (time frame: 5 days). 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 15 Aug 2014.