Abstract
Background: Less than half of all orthopaedic patients undergoing surgery report adequate pain relief. PAIN OUT is an international registry that collects and compares patient–reported outcomes to support quality improvement in postoperative pain management.
Aim: The aim of this study was to assess the impact of implementing a four–part perioperative pain management bundle by comparing pain outcomes pre– and post–bundle implementation in orthopaedic patients at a private hospital in Gauteng, South Africa.
Setting: A single private hospital providing elective orthopaedic surgical care in Gauteng, South Africa.
Methods: A pre–post observational audit was conducted using the PAIN OUT registry. Baseline data were collected from 86 patients (November 2021–March 2023), and post–implementation data from 105 patients (September 2023–March 2024). The bundle included patient education, non–opioid analgesia, regional anaesthesia and structured pain assessment.
Results: In the post–implementation group, 95.23% of participants had their pain assessed and reassessed regularly, compared with 58.13% at baseline. All participants received regional anaesthesia and/or wound infiltration, compared with 30.23% at baseline. Overall, 65.71% of patients received all four elements of the bundle compared with 0% before implementation. Total pain composite scores, pain–related interference and side effects of pain management significantly improved post–implementation. Fewer patients reported wanting more analgesia (21.9% vs 48.84%; p < 0.01).
Conclusion: Implementation of a four–part perioperative pain management bundle improved postoperative pain outcomes among orthopaedic patients and supports broader application of bundled approaches in diverse settings.
Contribution: This study provides South African PAIN OUT data and demonstrates the feasibility and effectiveness of a standardised perioperative pain management bundle in the private hospital setting.
Keywords: pain management; orthopaedic surgery; PAIN OUT; pain bundle intervention; pre–post study design.
Introduction
Worldwide, 240 million patients undergo major surgery annually.1 Less than half of all orthopaedic patients undergoing surgery report adequate pain relief.2 Unrelieved postoperative pain has numerous sequelae including delayed healing, increased morbidity, limited rehabilitation progress, higher rate of lung complications, depression, anxiety, prolonged duration of hospital stay, increased opioid use and heightened risk of developing chronic pain.3
Given these negative outcomes, efficient pain management from the preoperative period to discharge is essential.4 Evidence-based and ethical interventions improve healthcare delivery for patients, clinicians and healthcare organisations. PAIN OUT is an international quality improvement registry providing a web-based information system to improve the management of postoperative pain. Collaborating hospitals collect clinical data and patient-reported outcomes in a standardised way, using questionnaires available in different languages. Using these data, hospitals can benchmark their practices with the goal of identifying deficits, implementing improvements and measuring change over time.5
In 2023, a Serbian PAIN OUT study assessed whether a four-part perioperative pain management ‘bundle’ (a set of evidence-based interventions) would improve multidimensional pain-related patient-reported outcomes.6 The primary endpoint was a reduction in multidimensional pain composite score.
The four components of the perioperative pain management bundle were (Figure 17):
- Patient education: Handouts emphasising timely medication use, physical activity, enjoyable distractions, accurate pain scoring, communication with nurses, breathing exercises and social support.
- Non-opioid analgesia: Full intraoperative dose of one or two non-opioid analgesics, continued postoperatively (e.g. paracetamol, ketamine and Non-steroidal anti-inflammatory drugs (NSAIDS) such as diclofenac, lornoxicam and parecoxib).
- Regional anaesthesia: At least one technique intraoperatively (peripheral nerve block, neuraxial block or wound infiltration with local anaesthetic).
- Pain assessment and treatment: Postoperative pain assessed, documented and treated as indicated.
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FIGURE 1: Components of the four-part perioperative pain management bundle implemented in April 2023. The bundle included patient education, non-opioid analgesia, regional anaesthesia, and postoperative pain assessment and treatment. |
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The aim of this study was to assess the impact of implementing the four-part perioperative pain management bundle by comparing pain outcomes pre- and post-bundle implementation among orthopaedic patients at a private hospital in Gauteng, South Africa.
Research methods and design
Study design and setting
This was a pre–post observational audit study conducted at a private level 1 trauma hospital in Gauteng, South Africa, using the PAIN OUT registry. The national PAIN OUT South Africa study included 11 sites. The perioperative pain management bundle was introduced at this site in April 2023.
Participants
Eligible patients were ≥ 18 years of age, admitted for orthopaedic surgery and able to provide informed consent. Exclusion criteria included deafness, cognitive impairment, inability to communicate in English, Afrikaans, isiXhosa or isiZulu, or refusal to participate:
- Baseline audit (November 2021–March 2023): 86 patients entered into the registry.
- Bundle implemented (April 2023–September 2023) following staff training.
- Post–implementation audit (September 2023–March 2024): 105 patients entered into the registry.
Baseline recruitment was closed in March 2023 to allow bundle implementation, despite not reaching the target sample size of 100. Numbers of excluded patients was not consistently recorded; this is acknowledged as a limitation (Figure 2).
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FIGURE 2: Consolidated Standards of Reporting Trials (CONSORT)-style flow diagram adapted for a pre–post observational study and aligned with Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) principles. The diagram illustrates participant flow for the baseline audit (04 November 2021 – 29 March 2023) and post-implementation audit (01 September 2023 – 15 March 2024). Eligibility assessment numbers were not recorded (a limitation). Reasons for exclusion included deafness, cognitive impairment, language barrier and refusal (because of illness, pain or visitors). All patients included in the registry were analysed (baseline: n = 86; post-implementation: n = 105). |
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Intervention and data collection
Clinicians were trained in bundle principles via infographic handouts and structured sessions led by a physiotherapist and data collector. Training covered pain assessment, documentation and treatment.
Data were collected on postoperative day 1, after patients had returned to the ward for ≥ 6 h, by a trained data collector per the PAIN OUT protocols.8 Data were collected using a Process and Outcomes questionnaire:
- Process questionnaire: completed by the researcher, extracting demographics, medical history and analgesic use.
- Outcomes questionnaire: completed by patients, recording pain intensity (numerical rating scale), pain interference, affective impairment, adverse effects, perceptions of care, non–pharmacological treatments and chronic pain history.
Data were entered into the PAIN OUT registry, which assigns unique identifiers to ensure confidentiality and anonymity.
Sample size
A pragmatic audit approach was adopted. The target sample size of 100 patients per phase was not achieved at baseline (n = 86) because of recruitment challenges. Recruitment was not extended further because of resource constraints and hospital workflow limitations.
Statistical analysis
Registry data were reviewed and classified according to perioperative phases and classes of analgesia. The primary outcome was postoperative pain severity. Secondary outcomes included bundle adherence, pain interference, affective impairment, adverse effects and patient perceptions of care.
Descriptive statistics (median [interquartile range {IQR}]) summarised demographics, comorbidities, chronic pain profile, duration and type of surgery and bundle elements based on the non-normal distribution of the data. Categorical data were presented as percentages. Mann–Whitney U tests assessed whether postoperative pain severity decreased when all four bundle elements were implemented. Cohen’s d was calculated (Z scores) when p < 0.05, to establish effect size. Chi-square (χ2) tests compared categorical variables between audit phases.
Regression analysis was initially planned, but not feasible because of missing baseline data on non–opioid use. Missing data were handled by case–wise exclusion; no imputation was performed. Potential confounders (comorbidities, surgical complexity and chronic pain status) were described but not formally adjusted for because of limited sample size and non–randomised design.
Ethical considerations
Ethical approval for the national PAIN OUT registry, including this hospital site, was granted by Stellenbosch University (Ref: N19/10/140) with approval from the local hospital ethics board. Approval for the extraction and analysis of the collected data for this study was granted by the University of Cape Town (Ref: 455/2024). The study complied with the ethical principles of the Declaration of Helsinki.9
Results
Sociodemographic profile of participants
There were no statistically significant difference between participants in the baseline and post-implementation groups for age, weight or height (Table 1). The majority of participants completed the survey in English, with no statistically significant difference between groups in the language used to complete the survey.
| TABLE 1: Demographic and clinical characteristics of the baseline and post-implementation groups. |
Health profile of participants
Of the 89 (46.60%) participants presenting with comorbidities, the majority had more than one comorbidity. The most common presenting comorbidity was hypertension (n = 66; 34.55%) (Table 2). There was no statistically significant difference between groups in the number of comorbidities or in pre-existing chronic pain.
| TABLE 2: Surgical characteristics (N = 191). |
The participants had undergone a range of orthopaedic surgical procedures with no difference between groups. They spent a median of 1.67 h (1.15–2.25) in theatre with participants in the follow-up phase of the study, spending significantly less time in theatre (1.38 h [0.97–2.08] vs 2.02 h [1.52–2.50]; U = 2965.50; p < 0.01, Cohen’s d = 0.27). The participants had been back on the ward for a median of 24.33 h (21.52–27.32).
Bundle implementation: Was the bundle implemented?
Following the introduction of the perioperative pain management bundle, adherence to its components improved substantially (Table 3). Almost all patients in the post-implementation group received education on pain management (98.1% vs 65.1%; p < 0.01), and regular pain assessment increased markedly (95.2% vs 58.1%; p < 0.01). Use of regional anaesthesia or wound infiltration rose from 30.2% at baseline to 100% post-implementation (p < 0.01), and 72.4% of patients received the maximum dose of non-opioid analgesics (baseline data unavailable).
| TABLE 3: Delivery of the four elements of the bundle (N = 191). |
Overall, 65.7% of patients received all four bundle elements compared to none at baseline (p < 0.01). When considering only the three elements with complete data, 94.3% of post-implementation patients received all three versus 11.6% at baseline (p < 0.01), indicating a significant improvement in bundle delivery.
Pain outcomes: Did the bundle work?
Implementation of the bundle was associated with a significant improvement in overall pain composite scores (median 1.75 vs 2.25; p < 0.01) with a small effect size (Cohen’s d = 0.29) (Table 4). Although pain intensity scores did not differ significantly between groups, pain interference decreased markedly (median 0.25 vs 1.38; p < 0.01) with a moderate effect size (Cohen’s d = 0.48), indicating better functional recovery. Sleep interference showed the largest improvement (Cohen’s d = 0.52).
| TABLE 4: Pain composite scores and side effects of pain management (N = 191). |
Side effects of pain management also improved, with reductions in dizziness and drowsiness (overall side effect score median 0.75 vs 1.25; p < 001; Cohen’s d = 0.30). Additionally, fewer patients requested additional analgesia post-implementation (21.9% vs 48.8%; p < 0.01), suggesting greater satisfaction with pain control.
Discussion
This study aimed to evaluate whether implementing a four-part perioperative pain management bundle improved postoperative pain outcomes in orthopaedic patients. The most important findings were:
- High uptake of the bundle: 65.7% of patients received all four components post-implementation compared to none at baseline.
- Significant improvements in multidimensional pain outcomes: Pain composite scores and pain interference decreased, and side effects were reduced, although pain intensity remained unchanged.
- Greater patient satisfaction: Requests for additional analgesia dropped from 48.8% to 21.9%.
These findings suggest that the bundle was feasible and effective in improving functional recovery and reducing adverse effects, even though the worst pain scores did not change. This aligns with previous PAIN OUT research showing that multidimensional pain measures, rather than intensity alone, better reflect quality of pain management.6 Our results reinforce the value of multimodal strategies and patient education in perioperative care.2,4
Similar bundle approaches have demonstrated success internationally. For example, the Bundling Interventions To Enhance pain care quality (BITE) pain therapy bundle improved pain care quality through structured education, scheduled pain rounds and multimodal analgesia.10 Our findings are consistent with these reports, supporting bundles as practical tools for quality improvement in surgical pain management.
The reduction in side effects suggests decreased opioid reliance, an important consideration given the risks associated with opioid use in surgical patients.11 Multimodal analgesia, as promoted by the bundle, is recommended to minimise opioid-related complications and enhance recovery.11,12 This is particularly relevant in South Africa, where high rates of obesity and comorbidities increase perioperative risk.7,13 While obesity and chronic pain prevalence were notable in our sample, these factors were not the primary focus of this analysis and warrant further study.14,15,16,17,18
Strengths and limitations
Strengths include participation in an international registry, enabling benchmarking and standardised data collection.5,8 Limitations include missing baseline data for non-opioid dosing, small sample size and the non-randomised design, which introduces potential confounding. Baseline recruitment was extended for 16 months but closed to enable the timely implementation of the intervention. Differences in case mix and comorbidities cannot be fully excluded as alternative explanations for observed improvements.16,17 Future research should include larger samples, complete data capture and adjustment for confounders.
Conclusion
Implementation of a four-part perioperative pain management bundle was associated with improved multidimensional pain outcomes and reduced side effects in orthopaedic patients. The bundle is practical, feasible and has potential applicability across other surgical disciplines. Future research should focus on targeted quality improvement projects in procedures associated with moderate to severe pain to identify which bundle components most strongly influence patient outcomes and overall well-being.
Acknowledgements
This article is based on the research originally conducted as a part of the Mmed thesis titled ‘Enhancing perioperative pain management –what impact has a quality improvement pain management bundle had on perioperative pain management in orthopaedic patients at Union Hospital (Alberton, Gauteng)’ by Chandini Bundhun-Ragnuth, Cikizwa Mafanya and Romy Parker, submitted to the Department of Anaesthesia and Perioperative medicine, University of Cape Town in 2025. The thesis was supervised by Romy Parker and Cikizwa Mafanya. The thesis was reworked, revised and adapted into a journal article for publication.
Competing interests
The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.
CRediT authorship contribution
Chandini Bundhun-Ragnuth: Conceptualisation, Data curation, Formal analysis, Investigation, Methodology, Project administration, Supervision, Validation, Visualisation, Writing – original draft, Writing – review & editing. Romy Parker: Conceptualisation, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualisation, Writing – original draft, Writing – review & editing. Sean Chetty: Conceptualisation, Data curation, Formal analysis, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Visualisation, Writing – original draft, Writing – review & editing. Cikizwa Mafanya: Data curation, Investigation, Methodology, Validation, Visualisation, Writing – original draft, Writing – review & editing. All authors reviewed the article, contributed to the discussion of results, approved the final version for submission and publication, and take responsibility for the integrity of its findings.
Funding information
This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Data availability
Data sharing is not applicable to this article as no new data were created or analysed in this study.
Disclaimer
The views and opinions expressed in this article are those of the authors and are the product of professional research. They do not necessarily reflect the official policy or position of any affiliated institution, funder, agency or that of the publisher. The authors are responsible for this article’s results, findings and content.
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