Postoperative PainDOLAMINENCT02592460
Postoperative Pain and Polyamines-poor Diet (DOLAMINE)
A study testing poor-polyamines diet and high polyamines diet in people with Postoperative Pain, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- poor-polyamines diet and high polyamines diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jul 2017
- Phase
- Interventional
- 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
- foot ambulatory orthopedic surgery
- surgery scheduled at least 10 days after the inclusion consultation
Who cannot join
- other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)
- contraindication to tramadol or to NSAIDs
- pregnant or breastfeeding woman
- patient under legal protection
- patient's opposition to participate in the study
- poor understanding of French
- absence of affiliation to social security
- participation to another study
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Île-de-France Region, 75020
About this study
Official title: Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.
Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.
The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.
- Conditions
- Postoperative Pain
- Being tested
- poor-polyamines diet, high polyamines diet
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
poor-polyamines dietOther
Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery
high polyamines dietOther
Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery
| Study group | Role | What they receive |
|---|---|---|
| poor-polyamines diet | Experimental | Not described Receives: Other: poor-polyamines diet |
| high-polyamines diet | Active comparator | Not described Receives: Other: high polyamines diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.
The worst pain will be assessed retrospectively the eighth day after surgery
Measured: Eight days after surgery
Secondary outcomes (3)
Percentage of patients with a need for grade II analgesics
Measured: Eighth day after surgery
Overall tramadol consumption , expressed in mg.
Measured: Eight days after surgery
Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm
The worst pain will be assessed retrospectively the eighth day after surgery
Measured: Eight days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592460
- Sponsor's protocol ID
- WGF_2014-2
- Acronym
- DOLAMINE
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
- ClinicalTrials.gov ID
- NCT02592460
- Acronym / sponsor ID
- DOLAMINE / WGF_2014-2
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Oct 2015 (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.
Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.
Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.
The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| poor-polyamines diet | Experimental | Other: poor-polyamines diet |
| high-polyamines diet | Active comparator | Other: high polyamines diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- foot ambulatory orthopedic surgery
- surgery scheduled at least 10 days after the inclusion consultation
Key exclusion criteria (8 listed)
- other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)
- contraindication to tramadol or to NSAIDs
- pregnant or breastfeeding woman
- patient under legal protection
- patient's opposition to participate in the study
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 |
|---|---|---|
| poor-polyamines dietPatients in this will receive a poor-polyamines diet during a week before and a week after foot surgery | Other | poor-polyamines diet |
| high polyamines dietPatients in this will receive a high-polyamines diet during a week before and a week after foot surgery | Other | high-polyamines diet |
Primary outcome
Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.
Time frame: Eight days after surgery
The worst pain will be assessed retrospectively the eighth day after surgery
3 secondary outcomes
Percentage of patients with a need for grade II analgesics
Time frame: Eighth day after surgery
Overall tramadol consumption , expressed in mg.
Time frame: Eight days after surgery
Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm
Time frame: Eight days after surgery
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 15 Feb 2019.
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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?
A study testing poor-polyamines diet and high polyamines diet in people with Postoperative Pain, run by Groupe Hospitalier Diaconesses Croix Saint-Simon 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 8 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 15 Feb 2019. 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?
Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more. (time frame: Eight days after surgery). 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 Feb 2019.