Perioperative Δ9-THC for Postsurgical Pain

NCT01790555 | Unknown Phase 2 DMC

• 3 other identifiers: HEEL-2012-042012-005808-17NL43115.091.13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate treatment of postsurgical pain leads to better mobilization, shorter hospital stay, lower costs and higher patient satisfaction. In its treatment, frequent use is made of opioids. However, opioids have many side-effects. A possible add-on can be sought in THC, which has been shown to have possible analgesic and/or pain modulating effects in preclinical research. The purpose of this study is to investigate the analgesic and pain modulating effects of perioperative Namisol, a tablet containing THC, in patients that will undergo major abdominal surgery.

Conditions

Pain

Keywords

Postsurgical; Pain; THC; Sensitization

Outcome Measures

Primary Outcomes (1)

• Analgesic efficacy

  To investigate the analgesic efficacy of perioperative Namisol® for postsurgical pain at the day of surgery and in the first 5 days after abdominal surgery. Analgesic efficacy is measured as the difference in visual analog scale (VAS) area under the curve (AUC) for the day of surgery and the first 5 postoperative days between placebo and Namisol®.

  Daily until +5 days after surgery

Secondary Outcomes (1)

• Incidence of persistent continuous or intermittent postsurgical abdominal pain

  12 weeks after surgery

Other Outcomes (9)

• Total consumption of analgesics

  Daily until +5 days after surgery

• Postoperative Nausea and Vomiting (PONV)

  24 postoperative hours

• Perioperative cytokine levels

  Up to six weeks after surgery

Study Arms (2)

Namisol

EXPERIMENTAL

The study medication is given from the day before surgery (day -1: 5 mg in the afternoon and in the evening) up to the fifth day after surgery (day 0 to +5: 5 mg four times daily).

Drug: Namisol

Diazepam/Placebo

OTHER

The study medication is given from the day before surgery (day -1: 5 mg in the afternoon and in the evening) up to the fifth day after surgery (day 0 to +5: 5 mg four times daily). Before surgery, diazepam is used as an active comparator, to aid in blinding. After surgery, an inactive placebo is used as an inactive comparator.

Drug: Diazepam/placebo

Interventions

Namisol DRUG

Also known as: delta-9-tetrahydrocannabinol

Namisol

Diazepam/placebo DRUG

Diazepam/Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is at least 18 years old on the day the informed consent form will be signed.
• Patient has persistent or intermittent abdominal pain due to underlying intra-abdominal pathology.
• 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.
• 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.
• Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
• Patient is willing and able to comply with the lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other trial procedures.
• 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.

You may not qualify if:

• Patient is ineligible for the anesthesia protocol, as judged by the investigator.
• Patient is undergoing (abdominal wall) surgery with mesh implantation.
• Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one month prior to the day of screening.
• 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.
• 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.
• Patient demonstrates clinically significant deviations in the electrocardiogram (ECG) parameters at screening.
• Patient is at the moment of screening diagnosed with moderate to severe renal impairment as judged by the investigator.
• Patient is at the moment of screening diagnosed with moderate to severe hepatic failure as judged by the investigator.
• Patient has a presence or history of major psychiatric illness as judged by the investigator.
• 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.
• 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.
• Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine, MDMA, or amphetamines.
• 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.
• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Dronabinol; Diazepam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Harry van Goor, PhD MD FRCS

  Radboud University Nijmegen Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dagmar CM van Rijckevorsel, MD

CONTACT

0243617365; d.vanrijckevorsel@student.ru.nl

Marjan de Vries, MSc

CONTACT

0243617365; marjan.devries@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 13, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 23, 2013

Record last verified: 2013-02

Locations

NL (1)