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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Pregnant women

Minor, adult under guardianship or benefiting from a legal protection

Oncological surgery

Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polyamine Deficient Diet

    Other intervention

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

Treatment groups

278 Participants
are divided into 2 treatment groups
Group A: Polyamine deficient dietExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
72 hours post-surgery

Secondary outcomes

1

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

Time frame
15 days post-surgery
2

Change in the main dimension of pain

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

Time frame
6 months post-surgery
3

Change of the recovery time of the gas transit

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

Time frame
6 months post-surgery
4

Change of duration of urinary catheterization

Recovery of spontaneous urination post-surgery (in days)

Time frame
6 months post-surgery

Other outcomes

Sponsors and contacts

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Nantes University Hospital

Lead sponsor

Centre de Recherche en Nutrition Humaine Ouest (CRNH)

Collaborator