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Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery (POLYAMAL)

Primary Purpose

Digestive System Surgical Procedures

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Polyamine Deficient Diet

About this trial

This is an interventional treatment trial for Digestive System Surgical Procedures focused on measuring Abdominal surgery, Polyamine, Postoperative pain, Morphine, Hypersensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult (>18 years)
Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
Written informed consent form obtained from the patient
Affiliated to the social security

Exclusion Criteria:

Pregnant women
Minor, adult under guardianship or benefiting from a legal protection
Oncological surgery
Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
Drug addicts patients, or under opiate dependency
Chronic pain patients (pain over 3 months)
Patients in nursing home or convalescence home (diet non possible in institution)
Planned hospitalisation before the intervention (during the 7 days before the surgery)
Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month and/or > 15% in 6 months, albumin at inclusion <15g/l)
Patient refusing the possibility to change his eating habits
Oral feeding impossible preoperatively
Patient not able to express himself on their pain (silent, …)
Decompensated psychiatric pathologies (severe depression syndrome,…)
Patient unable to understand the protocol and/or to give his informed consent

Sites / Locations

CHRU Brest La Cavale BlancheRecruiting
Hôpital Louis Mourier from Ap-HP
CHD VendéeRecruiting
CHU Nantes Hôtel DieuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Polyamine deficient diet

Control

Arm Description

Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Usual Diet plus two snacks

Outcomes

Primary Outcome Measures

To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group

To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room

Secondary Outcome Measures

Change in the analgesics consumption post-operatively

Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery

Change in the main dimension of pain

Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)

Change of the recovery time of the gas transit

Evaluation of the time to recover the gas transit post-surgery (in days)

Change of duration of urinary catheterization

Recovery of spontaneous urination post-surgery (in days)

Change in the delay before the first postoperative lift

Time before walking post-surgery (in days)

Change in length of hospitalisation stay and sick leave

Hospitalisation time and sick leave (in days)

Change in neuropathic pain: Neuropathic pain scale (DN4)

Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.

Change in global health status

Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score.

Change of the recovery ability

Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)

Change in the quality of life

Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)

Full Information

NCT ID

NCT04219956

First Posted

January 3, 2020

Last Updated

May 26, 2023

Sponsor

Nantes University Hospital

Collaborators

Centre de Recherche en Nutrition Humaine Ouest (CRNH)

1. Study Identification

Unique Protocol Identification Number

NCT04219956

Brief Title

Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

Acronym

POLYAMAL

Official Title

A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2020 (Actual)

Primary Completion Date

April 2027 (Anticipated)

Study Completion Date

November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

Collaborators

Centre de Recherche en Nutrition Humaine Ouest (CRNH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.

Detailed Description

Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity. N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia. Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively. Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body. The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity. The medico-economic impact will be observed during this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Digestive System Surgical Procedures

Keywords

Abdominal surgery, Polyamine, Postoperative pain, Morphine, Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

The anesthetist is blinded to the arm of attribution

Allocation

Randomized

Enrollment

278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Polyamine deficient diet

Arm Type

Experimental

Arm Description

Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Arm Title

Control

Arm Type

No Intervention

Arm Description

Usual Diet plus two snacks

Intervention Type

Other

Intervention Name(s)

Polyamine Deficient Diet

Intervention Description

Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet

Primary Outcome Measure Information:

Title

To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group

Description

Time Frame

72 hours post-surgery

Secondary Outcome Measure Information:

Title

Change in the analgesics consumption post-operatively

Description

Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery

Time Frame

15 days post-surgery

Title

Change in the main dimension of pain

Description

Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)

Time Frame

6 months post-surgery

Title

Change of the recovery time of the gas transit

Description

Evaluation of the time to recover the gas transit post-surgery (in days)

Time Frame

6 months post-surgery

Title

Change of duration of urinary catheterization

Description

Recovery of spontaneous urination post-surgery (in days)

Time Frame

6 months post-surgery

Title

Change in the delay before the first postoperative lift

Description

Time before walking post-surgery (in days)

Time Frame

6 months post-surgery

Title

Change in length of hospitalisation stay and sick leave

Description

Hospitalisation time and sick leave (in days)

Time Frame

6 months post-surgery

Title

Change in neuropathic pain: Neuropathic pain scale (DN4)

Description

Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.

Time Frame

6 months post-surgery

Title

Change in global health status

Description

Time Frame

1 month before surgery, 1 month and 6 months post-surgery

Title

Change of the recovery ability

Description

Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)

Time Frame

1 month before surgery, 1 month and 6 months post-surgery

Title

Change in the quality of life

Description

Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)

Time Frame

1 month before surgery, 1 month and 6 months post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult (>18 years) Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications) Written informed consent form obtained from the patient Affiliated to the social security Exclusion Criteria: Pregnant women Minor, adult under guardianship or benefiting from a legal protection Oncological surgery Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery) Drug addicts patients, or under opiate dependency Chronic pain patients (pain over 3 months) Patients in nursing home or convalescence home (diet non possible in institution) Planned hospitalisation before the intervention (during the 7 days before the surgery) Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month and/or > 15% in 6 months, albumin at inclusion <15g/l) Patient refusing the possibility to change his eating habits Oral feeding impossible preoperatively Patient not able to express himself on their pain (silent, …) Decompensated psychiatric pathologies (severe depression syndrome,…) Patient unable to understand the protocol and/or to give his informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claire Blanchard, MD-PhD

Phone

+33 (0)2 40 08 30 22

claire.blanchard@chu-nantes.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Laetitia Berly

Phone

+33 (0)2.53.52.62.04

laetitia.berly@chu-nantes.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire Blanchard, MD-PhD

Organizational Affiliation

Nantes University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHRU Brest La Cavale Blanche

City

Brest

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jérémie Thereaux, MD PhD

Facility Name

Hôpital Louis Mourier from Ap-HP

City

Colombes

ZIP/Postal Code

92700

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David MOSZKOWICZ, Pr

david.moszkowicz@aphp.fr

Facility Name

CHD Vendée

City

La Roche-sur-Yon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emeric Abet

Facility Name

CHU Nantes Hôtel Dieu

City

Nantes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blanchard Claire, MD PhD

First Name & Middle Initial & Last Name & Degree

Tristan Greilsamer, MD

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

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