The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

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