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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
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.
Identical to the Namisol arm.
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Average VAS pain
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.
Time frame: Baseline versus day 52
Electroencephalogram (EEG)
Evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and spontaneous brain activity will be measured in the electroencephalogram (EEG).
Time frame: Baseline versus day 52
Quantitative Sensory Testing (QST)
Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST).
Time frame: Baseline versus day 15 and day 52
Depression and (pain related) anxiety
Depression and (pain related) anxiety measured by questionnaires.
Time frame: Baseline versus day 52
Pharmacodynamic parameters
Pharmacodynamics measured by body sway and questionnaires (VASBond \& Lader and VASBowdle)
Time frame: Baseline versus day 15 and day 52
Safety parameters
* Laboratory * Electrocardiogram (ECG) * Heart Frequency (HF) / Blood Pressure (BP) * Adverse Events (AE)
Time frame: Baseline until follow-up (day 59-61)
Quality of life
Quality of life will be evaluated by questionnaires
Time frame: Baseline versus day 52
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