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

Digestive System Surgical Procedures Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04219956
• Other study ID #: RC19_0023
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: November 2027

Study information

• Verified date: May 2023
• Source: Nantes University Hospital
• Contact: Claire Blanchard, MD-PhD
• Phone: +33 (0)2 40 08 30 22
• Email: claire.blanchard[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: November 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Surgical Procedures
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
France	CHRU Brest La Cavale Blanche	Brest
France	Hôpital Louis Mourier from Ap-HP	Colombes
France	CHD Vendée	La Roche-sur-Yon
France	CHU Nantes Hôtel Dieu	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Centre de Recherche en Nutrition Humaine Ouest (CRNH)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	72 hours post-surgery
Secondary	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	15 days post-surgery
Secondary	Change in the main dimension of pain	Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)	6 months post-surgery
Secondary	Change of the recovery time of the gas transit	Evaluation of the time to recover the gas transit post-surgery (in days)	6 months post-surgery
Secondary	Change of duration of urinary catheterization	Recovery of spontaneous urination post-surgery (in days)	6 months post-surgery
Secondary	Change in the delay before the first postoperative lift	Time before walking post-surgery (in days)	6 months post-surgery
Secondary	Change in length of hospitalisation stay and sick leave	Hospitalisation time and sick leave (in days)	6 months post-surgery
Secondary	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.	6 months post-surgery
Secondary	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.	1 month before surgery, 1 month and 6 months post-surgery
Secondary	Change of the recovery ability	Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)	1 month before surgery, 1 month and 6 months post-surgery
Secondary	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)	1 month before surgery, 1 month and 6 months post-surgery