The analgesic efficacy of perioperative delta-9-THC (Namisol) in patients undergoing major abdominal surgery: a randomized, double blinded, placebo-controlled, parallel desig

Phase 2

Completed

Conditions: postchirurgische pijn
pain after surgery
10017998

Registration Number: NL-OMON38617

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Patient is at least 18 years old on the day the informed consent form will be signed.
2. Patient has persistent or intermittent abdominal pain due to underlying intra-abdominal pathology.
3. If the patient uses concomitant analgesic medication the dosage intake is stable for at least two weeks prior to the day of screening. Stable dose intake is defined as a daily equivalent sum of intake according to medical prescription within a small deviation range as judged by the investigator.
4. Patient is undergoing elective, open abdominal surgery with planned use of an epidural catheter. The surgical procedure has an estimated duration of at least two hours, excluding the time to induce anesthesia.
5. Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
6. Patient is willing and able to comply with the lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other trial procedures.
7. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria

1. Patient is ineligible for the anesthesia protocol, as judged by the investigator.
2. Patient is undergoing (abdominal wall) surgery with mesh implantation.
3. Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one month prior to the day of screening.
4. Patient has (a history of) a medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
5. Patient uses amitriptyline or other concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
6. Patient demonstrates clinically significant deviations in the electrocardiogram (ECG) parameters at screening.
7. Patient is at the moment of screening diagnosed with moderate to severe renal impairment as judged by the investigator.
8. Patient is at the moment of screening diagnosed with moderate to severe hepatic failure as judged by the investigator.
9. Patient has a presence or history of major psychiatric illness as judged by the investigator.
10. Patient demonstrates clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
11. Patient has a history of sensitivity/idiosyncrasy to THC or diazepam, compounds related to these compounds, or to any other related drug used in the past.
12. Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine, MDMA, or amphetamines.
13. Female patient intends to conceive a child, is pregnant or breastfeeding, or does not use acceptable birth control measures including oral contraceptives, intrauterine devices or mechanical methods during the course of the study.
14. Patient participated in another investigational drug study within 90 days prior to the first dose and/or participated in more than 2 clinical trials in the last 365 days.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcome is postsurgical pain intensity during the first five<br /><br>postoperative days, reflected by the primary endpoint: the area under the curve<br /><br>of the VAS scores at rest on the day of surgery and in the first five days<br /><br>after surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome is the incidence of persistent postsurgical pain after 6,<br /><br>12, and 24 weeks after surgery. In addition to the primary and secondary<br /><br>outcomes, several other outcome parameters will be collected. These include the<br /><br>area under the curve of the VAS scores after coughing on the day of surgery and<br /><br>in the first five days after surgery, measures of postsurgical pain intensity<br /><br>during the first 24 postoperative weeks, measures of analgesic efficacy,<br /><br>central nervous system processing and sensitization in the first 5 days and<br /><br>after 6, 12, and 24 weeks after surgery, postoperative sedation level, and<br /><br>immune system response during 72 hours after surgery and after 6 weeks are<br /><br>investigated. In addition, questionnaires are filled out to examine parameters<br /><br>related to side effects and postoperative recovery.</p><br>