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| Name | Class |
|---|---|
| European Union | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delta-9-tetrahydrocannabinol (namisol) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetrahydrocannabinol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline versus day 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline versus day 52 |
| Quantitative Sensory Testing (QST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry van Goor, MD, PhD | Radboud University Nijmegen Medical Centre, department of surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27720917 | Derived | de Vries M, van Rijckevorsel DCM, Vissers KCP, Wilder-Smith OHG, van Goor H; Pain and Nociception Neuroscience Research Group. Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1079-1086.e4. doi: 10.1016/j.cgh.2016.09.147. Epub 2016 Oct 5. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D015746 | Abdominal Pain |
| D059350 | Chronic Pain |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Identical to the Namisol arm. |
|
Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST). |
| Baseline versus day 15 and day 52 |
| Depression and (pain related) anxiety | Depression and (pain related) anxiety measured by questionnaires. | Baseline versus day 52 |
| Pharmacodynamic parameters | Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle) | Baseline versus day 15 and day 52 |
| Safety parameters |
| Baseline until follow-up (day 59-61) |
| Quality of life | Quality of life will be evaluated by questionnaires | Baseline versus day 52 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D059226 | Nociceptive Pain |