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.