Abdominal Pain, Chronic Pain, Postsurgical Pain
Conditions
Keywords
postsurgical pain, abdominal pain, visceral pain, chronic pain
Brief summary
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.
Interventions
The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
DRUGPlacebo
Identical to the Namisol arm.
Sponsors
European Union
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Pain should have developed after a surgical procedure * Pain duration exceeding 3 months, and average NRS≥3 * Stable doses intake of analgesics for the past 2 months * The patient has been informed about the study, understood the information and signed the informed consent form
Exclusion criteria
* Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis * Patient took cannabinoids on a regular basis for at least one year * Patient does not feel a pinprick test in the lower extremities * Patient has a body mass index (BMI) above 36,0 kg/m2 * Patient suffers from serious painful conditions other than chronic pancreatitis * Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient * Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient * Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons * Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG) * Patient has an actual moderate to severe renal impairment * Patient has an actual moderate to severe hepatic impairment * Patient has a presence or history of major psychiatric illness * Patient has experienced an epileptic seizure in the past * Patient demonstrates clinically significant laboratory abnormalities * Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines * Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test * Patient has a history of sensitivity / idiosyncrasy to THC * Patient has a known or suspected lactose intolerance * Female patient is pregnant or breastfeeding * Patient intends to conceive a child during the course of the study * Patient participates in another investigational drug study * Patient has a clinical significant exacerbation in illness * Patient is unwilling or unable to comply with the lifestyle guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average VAS pain | Baseline versus day 52 | The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a pain diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Sensory Testing (QST) | Baseline versus day 15 and day 52 | Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST). |
| Depression and (pain related) anxiety | Baseline versus day 52 | Depression and (pain related) anxiety measured by questionnaires. |
| Electroencephalogram (EEG) | Baseline versus day 52 | Evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and spontaneous brain activity will be measured in the electroencephalogram (EEG). |
| Safety parameters | Baseline until follow-up (day 59-61) | * Laboratory * Electrocardiogram (ECG) * Heart Frequency (HF) / Blood Pressure (BP) * Adverse Events (AE) |
| Quality of life | Baseline versus day 52 | Quality of life will be evaluated by questionnaires |
| Pharmacodynamic parameters | Baseline versus day 15 and day 52 | Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle) |
Countries
Netherlands
Outcome results
None listed