A Comprehensive Patient And Public Involvement Programme Evaluating Perception Of Cannabis-derived Medicinal Products In The Treatment Of Acute Postoperative Pain, Nausea And VomitingUsing A Qualitative Thematic FrameworkSimon Erridge1, Marie Miller2, Tamara Gall1, Antonio Costanzo3, Barbara Pacchetti3, Mikael H Sodergren1,3
1. Department of Surgery and Cancer, Imperial College London, London, UK 2. Imperial Clinical Trials Unit, Imperial College, London, UK 3. Emmac Life Sciences, London, UK
Surgeons are seeking to reduce postoperative opioid use due
to the significant side-effect profile. There is evidence that
cannabis-derived medicinal products (CDMPs) have anti-
emetic, anti-nociceptive and anti-inflammatory properties via
the endocannabinoid system. Additionally, they demonstrate
additive analgesic effects through the μ- and κ- opioid
receptors (1). A recent UK survey study highlighted that 76%
of participants would be open to taking CDMPs if prescribed
(2). A study of perioperative patients in the US indicated that
81.5% and 82% of patients would be willing to take CDMPs for
postoperative and chronic pain respectively (3).
Aims: The objective of this patient and public involvement
(PPI) program was to determine perception of perioperative
CDMPs in our local population and to inform design and
clinical end-points of a double-blinded randomized controlled
clinical trial.
Introduction
The PPI programme consisted of a focus group (n=14) and
semi-structured interviews (n=4). For each session,
introductions included a presentation of the proposed
placebo-controlled randomized controlled trial of CDMPs with
current analgesic gold standard (figure. proposed trial design).
Qualitative data analysis was based on the framework
methodology. Verbatim transcriptions were coded
categorically into analytical frameworks for thematic analysis.
Emergent themes and associated degree of consensus/dissent
were determined.
Methods
The perception of postoperative cannabinoid therapy was
overwhelmingly positive in this West London population.
These results are concordant with other investigations into
public perceptions of CDMPs (2,3). The data from this
thematic analysis can inform protocol development of
clinical trials to determine analgesic and anti-emetic
properties of cannabinoids.
Conclusion
References(1) Russo EB, Marcu J. Cannabis pharmacology: the usual suspects and a few promising leads.
Advances in Pharmacology. Elsevier; 2017. pp. 67-134.
(2) Populus. Populus explores public perceptions on cannabis. Available from: https://www.populus.co.uk/2018/11/populus-explores-public-perceptions-on-cannabis/
(3) Khelemsky Y, Goldberg AT, Hurd YL, Winkel G, Ninh A, Qian L, et al. Perioperative patient beliefs regarding potential effectiveness of marijuana (cannabinoids) for treatment of pain:
a prospective population survey. Regional anesthesia and pain medicine. 2017;42(5): 652-
659.
9.09
12.88
14.54
9.67
Framework AnalysisCDMP-product perceptions
Medicinal BenefitsParticipants believe CDMPs would have a role to play in acute
post-operative pain.
Side-effectsNegative perceptions include addiction, dysphoria and adverse
psychiatric outcomes. Perceived better side-effect profile
compared with opioids.
SafetyCDMPs were viewed as safe by our population for perioperative use.
Trial perceptions
AdministrationSublingual/oral administration was most acceptable route of
administration. Smoking least acceptable route.
ParticipationAll participants theoretically agreed with study protocol and
to be randomized in such a trial.
Primary OutcomesDecrease in opioid-dependence at 5 days post-operatively was
agreed as an appropriate clinical end-point.
Secondary OutcomesParticipants believed it was important to record pain scores, nausea
and vomiting, quality of life and side-effects.
Patients undergoing liver/pancreas resection
Proposed Trial Design
InterventionGold-standard
postoperative analgesia
+ CDMP
ControlGold-standard
postoperative analgesia
+ Placebo
Randomization
5-day post-operative follow up
Following PPI programme amendments
1o Outcomes- Change in patient-
controlled analgesia
use
2o Outcomes- Pain scores
- Frequency of PONV
- Side effects
Added from PPI
- Multi-dimensional
pain assessment
- Severity of PONV
- Quality of Life score
- 6x daily data
capture (inc. morning
for night sx)
ResultsThe participants were composed of a representative cohort of
patients and relatives (M:F = 1:1, age range 33-85). The
analytical framework consisted of 24 coded themes, with the
most salient presented opposite.
