Acute postoperative pain management protocols in podiatric surgery within Australia: a Delphi study

Pain is defined as a subjective unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage [1‐3]. Postoperative pain stems from various causes such as neuronal damage, haematoma and oedema, infection, stiff joints, and intraoperative trauma [4]. Acute postoperative pain has been associated with an unacceptable negative affect on a patient’s quality of life, sleep and physical function, delayed return to normal daily activities, an increase in the postoperative hospital burden and economic costs due to re-admission, and potential development of chronic pain [2, 5, 6]. Orthopaedic patients have been found to report the highest incidence of pain compared with other types of surgical procedures, with more than half having suboptimal control [7‐9]. Effective postoperative pain management should aim to minimise discomfort, facilitate early mobilisation and functional recovery, and prevent acute pain from developing into chronic pain [2, 6].

There is a vast amount of literature pertaining to strategies for acute postoperative pain management, with a recent upward trend into investigations for procedure specific protocols. The reason for this is manifold; the repercussions of surgically induced pain can delay healing and normal return to activities, prolong hospital stay, cause emotional distress, prompt fear and avoidance of surgery, and negatively impact a patient’s overall quality of life [7, 10‐13]. Current advice for postoperative pain management includes general guidelines and multimodal approaches for acute pain management [10]. That said, there is recognition that such information should be procedure-specific to better tailor the analgesic efficacy of drugs between various types of surgery. Optimal dynamic pain relief has been found to be important for accelerated postoperative rehabilitation and minimising the unwanted side effects of certain drug classes on particular surgeries, as well as to potentially reduce the incidence of opioid-associated adverse effects with the use of non-opioid analgesics [14]. While a substantial portion of this area of orthopaedic-related research has focussed on postoperative pain management for larger surgeries such as total hip and knee arthroplasty, there is a paucity of evidence to guide pain management for foot and ankle surgery [5, 12, 15].

There have been suggestions in the literature for pain management strategies after elective foot and ankle surgery, however, these recommendations are dated and apply to practitioners living outside of Australia. Moreover, there is little evidence-based literature describing an analgesic protocol that factors in the spectrum of foot and ankle surgery. It is important for practitioners in Australia to have country-specific guidelines on prescribing strategies for acute postoperative pain management, given the differences between a practitioner’s access to certain analgesic drugs across the globe. The purpose of this study was to address this gap in the literature and develop a guide for acute postoperative pain management for podiatric day surgery in Australia. This research also aimed to identify opportunities to improve the current list of scheduled medicines available to podiatric surgeons in Australia and reach a consensus on the best practice for acute postoperative pain management. Meyr and colleagues stated that while a clinical consensus statement does not represent clinical practice guidelines, formal evidence reviews, recommendations, or evidence-based guidelines, in the scenario where high-level evidence is not always available, a clinical consensus statement reflects information from a group of experts based on the best available evidence, clinical experience, and common sense [12].

The Delphi method was chosen for the study design as it is a suitable means for building consensus on a specific topic [16‐18]. The Delphi process is typically conducted over a series of two or more sequential surveys known as “rounds”. While a varied number of rounds have been suggested for the Delphi process in the literature, 3 rounds were employed in this study as this number of iterations has been proposed to be sufficient for collecting the required data to reach a consensus in most scenarios [16]. It has been suggested multiple iterations through a series of surveys allows and encourages panellists to re-assess and have the option to amend their initial judgements about information provided in the previous rounds [16, 17].

The surveys in a Delphi study draw from a knowledgeable participant pool known as the “panellists” [16, 17]. Twelve panellists who met the inclusion criteria of being a podiatric surgeon with at least 3 years of experience prescribing medications or an anaesthetic consultant with pain management experience in podiatric or orthopaedic foot and ankle surgery were invited to participate in this study. No patients participated directly in this study. These panellists were recruited from their respective professional bodies including the Australian Association of Podiatric Surgeons (AAPS) and Australasian College of Podiatric Surgeons (ACPS), from private hospitals, as well as via the “snowball sampling” technique whereby panellists who had already been invited provided nominations for other candidates who also met the inclusion criteria. Given the niche area of podiatric surgery in Australia, snowball sampling was the most viable option to recruit from an already small pool of potential panellists, and offered accessibility to anaesthetic consultants who may work outside of the private sector where Australian podiatric surgeons solely practice. It was an assumption of this study that a participant who meets the inclusion criteria has sufficient clinical experience to provide thoughtful independent contribution regardless of their historical podiatric surgical training. Identification of a participant’s training may compromise the anonymity of their participation. It was therefore not of interest to collect this data nor assume its relevance for obtaining an agreed consensus for the use of medications in the acute postoperative setting.

The first round commenced with an open-ended questionnaire consisting of 15 questions that covered several topics on acute postoperative pain management after podiatric surgery in Australia. Conception of the initial open-ended survey was driven by the investigators who have clinical experience with prescribing for acute postoperative pain following podiatric surgery, including a practised podiatric surgeon with 8 years of prescribing, and a podiatric surgery registrar with 2 years of prescribing. After scoping the literature, the investigators identified that there was limited evidence to guide acute pain management after elective foot and ankle surgery in Australia. As alluded to earlier, at the time of conception, the evidence available related to practitioners outside of Australia, who have different access to certain analgesic drugs. Hence, as this Delphi study was a novel investigation with no reference point, the content of the initial open-ended survey began with broader questions that attempted to cover postoperative analgesic prescribing for the entire spectrum of foot and ankle surgery, to then synthesising a list of essential analgesics and/or a prescription plan for acute postoperative pain management in Australia based on panellist responses.

For the second survey round, a series of 55 statements was then developed based on information provided by the panellists from the first round. The questions were synthesised directly from answer provided, and any similar responses were grouped into one statement. The authors opted to present the panellists’ use of each proposed analgesic drug according to their patient’s pain severity levels. The pain severity levels were categorised as mild, moderate, and severe. Each category was defined according to an 11-point numeric rating scale (NRS) as follows: no pain was an NRS of 0 out of 10, while mild, moderate, and severe levels were an NRS of 1 to 3 out of 10, 4 to 7 out of 10, and 8 to 10 out of 10 respectively [19, 20]. Panellists were invited to rate the appropriateness of each of the 55 statements from 1 (extremely inappropriate) to 9 (extremely appropriate) using a Likert scale, similar to that used in Meyr and colleagues’ clinical consensus study [12].

The responses from the second round were analysed and grouped from 1 to 3 (inappropriate), 4 to 6 (neither appropriate nor inappropriate), and 7 to 9 (appropriate). The final survey presented the same 55 statements to the panellists as the previous round, however, this time a percentage summary demonstrating the initial consensus was included, and panellists were afforded the opportunity to revise their responses in light of this new information. Individual responses were not included with each round due to the limitations of the online survey tool used. All responses from each round were kept anonymous except to the research investigator, to preserve the integrity of the data.

This study adopted the design used in the modified Delphi study by Meyr and colleagues, and consensus was considered when majority of the panellists agreed the statement [12]. The main statistics typically used to present the collective judgements of respondents are measures of central tendency and level of dispersion [21]. The data was cleaned and analysed using IBM SPSS to obtain basic descriptive statistics such as the mean, median, mode, and standard deviation. Demographic data was also collected for background information. Any incomplete surveys or participant drop outs were omitted from the final analyses.

Ethics approval was obtained from the University of Western Australia Human Research Ethics Committee prior to the commencement of participant recruitment (2021/ET000438). Written informed consent was obtained from all panellists before commencement of data collection using the online survey platform, Qualtrics. The study was conducted over a period of 11 weeks.

Twelve panellists initially consented to participate in this study, however, due to the nature of the multiple iterations associated with the Delphi technique, drop out was expected. Ten panellists remained after the final survey round for inclusion in the study, with 1 podiatric surgeon and 1 anaesthetic consultant dropping out from the study. These panel members consisted of podiatric surgeons with endorsements for scheduled medicines (n = 8) and anaesthetic consultants (n = 2) practicing within Australia. Clinical experience ranged from 4 years to 30 years (median, 9.5 years) prescribing in clinical practice.

The consensus results of all 55 statements that were proposed are shown in Tables 1, 2, 3, 4, 5, 6, 7 and 8, with the mode of the grouped agreement level demonstrating the majority vote for each Delphi statement. The general pattern of agreement regarding drug prescribing was that for mild and moderate acute postoperative pain, oral medications such as paracetamol, paracetamol sustained release (SR) 665 mg, and/or a cyclooxygenase-2 (COX-2) inhibitor were agreed on as an appropriate management option, although there was an equal number of votes that deemed paracetamol SR 665 mg as neither appropriate nor inappropriate for moderate pain. An oral non-selective non-steroidal anti-inflammatory drug (NSAID) was deemed neither appropriate nor inappropriate for acute postoperative pain management at the mild and moderate pain severity levels. In addition to these drugs, an oral opioid combination product and/or oral tapentadol immediate release (IR) was also agreed as appropriate for management of moderate pain.

For severe acute postoperative pain, oral paracetamol and/or an oral COX-2 inhibitor, and oral formulations of oxycodone, tramadol, tapentadol IR and SR, and/or sublingual buprenorphine were voted as an appropriate management option. In this scenario, oral paracetamol SR 665 mg was considered neither appropriate nor inappropriate, while an oral NSAID or opioid combination product were tied in votes as appropriate and neither appropriate nor inappropriate. All other statements in the Delphi study were accepted as appropriate by the majority of panellists.

In summary, the agreed approach to acute postoperative pain management for podiatric surgeons in Australia was with a stepwise approach, utilising multimodal therapy, and reserving oral opioids for breakthrough pain. Additionally, there was consensus for podiatric surgeons in Australia to have wider access to alternative analgesics and anti-emetics that have similar or improved efficacies with better safety profiles.