Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Aalborg University Hospital
Aalborg, Denmark
Total gastrointestinal transit time
Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Time frame: From day 4 to day 8
Colorectal transit time
Difference in hours from the entering in the colon of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment
Time frame: From day 4 to day 8
Constipation symptoms
Measured on the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire (ranging from 0 (symptom absent) to 4 (very severe).
Time frame: From day 1 to day 10
Bowel movement frequency
Number of spontaneous bowel movements per day
Time frame: From day 1 to day 10
Stool consistency
Rated on the Bristol Stool Form Scale (ranging from type 1 (constipation) - type 7 (diarrhea))
Time frame: From day 1 to day 10
Gastrointestinal symptoms
Measured on the Gastrointestinal Symptom Rating Score (GSRS) questionnaire (ranging from 0 (no discomfort) to 6 (very severe discomfort)
Time frame: Day 1 and day 10
Opioid-induced constipation
Measured by the Bowel Function Index (BFI) questionnaire (ranging from 0 (not at all) to 100 (very strong).
Time frame: Day 1 and day 10
Diagnostic evaluation of opioid-induced constipation
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Assessed using the Rome IV C6 criteria consisting of 7 items rated as either true or false. 2 or more items rated as "true" indicates functional constipation
Time frame: Day 10
Colonic motility patterns
Number of motility patterns in the colon measured by the 3D Transit Capsule
Time frame: From day 4 to day 8
Opiate withdrawal symptoms
Measured by the Subjective Opiate Withdrawal Scale (ranging from 0 (not at all) to 4 /extremely)
Time frame: Day 13, 14 or 15
Colon volume
Volumetric quantification of the colon measured using T2-weighted MRI images
Time frame: Day 10
Colonic water content
Analysis of colonic water content measured using heavily T2-weighted MRI images
Time frame: Day 10
Gastric half emptying time
Analysis of gastric half emptying time after ingestion of a standardized meal measured by MRI
Time frame: Day 1 and day 10
Gastric contraction assessment
Analysis of gastric contraction amplitude after ingestion of a standardized meal measured by MRI
Time frame: Day 1 and day 10
Gastric contraction assessment
Analysis of gastric contraction frequency after ingestion of a standardized meal measured by MRI
Time frame: Day 1 and day 10
Small bowel motility assessment
Analysis of small bowel motility after ingestion of a standardized meal measured using dynamic MRI images. A semi-automated analysis software enables registration of small bowel motility with the calculation of regional motility maps and quantification of motility indices.
Time frame: Day 1 and day 10
Small bowel water content
Analysis of small bowel water content measured using heavily T2-weighted MRI images
Time frame: Day 1 and day 10