Postoperative continuous-flow cryocompression therapy in the acute recovery phase of hip fracture surgery—A randomized controlled clinical trial
Introduction
Hip fractures frequently occur in the elder population, and global incidence is steadily rising [1]. Mainly due to aging of the population, global incidence figures are projected to increase by 1–3% annually the coming decades [1]. Early surgical fixation with direct postoperative mobilization remains the cornerstone of hip fracture treatment in nearly all cases, and targets preservation of pre-fracture functional status.
The severe postoperative pain hip fracture patients experience has led to various treatment options ranging from nerve blockades, loco-regional opioid administration, and to systemic (opioid) analgesia therapy [2], [3]. The multitude of treatment options illustrates that adequate pain control continues to be a challenge in this condition. Most elderly patients experience physiological decline in organ function (such as renal or hepatic function) that can alter the pharmacology of analgesics [4]. In addition, comorbidities and polypharmacy render elderly susceptible to drug interactions and adverse events, which puts them at risk for inferior pain treatment [4], [5]. The need for adequate pain relief is evident, as inferior pain treatment has been associated with delayed ambulation, which leads to an extended hospital admission, to poorer short and mid-term functional outcome, and development of postoperative delirium [6], [7]. Taken together, these altered pharmacodynamics and kinetics narrow the therapeutic window, and combined with the painful nature of a hip fracture this leads to increased difficulty in providing adequate analgesia to hip fracture patients [2].
The injury sustained during a hip fracture causes fracture site bleeding that render 40% of admitted hip fracture patients anaemic [8]. The additional blood loss that fracture repair encompasses increases this figure to 93% [8]. This high incidence of anaemia is problematic since it negatively impacts length of stay (LOS), readmission rates, and odds of death [8]. However, erythrocyte transfusion delays wound healing and increases risk of infection, hence the need for transfusion should be carefully considered, or avoided completely if feasible [9]. Continuous-flow cryocompression therapy (CFCT) combines the flow of ice-cold water with a dynamic intermittent compression adjunct aiming to result in haemostasis as well as providing analgesia in a non-pharmacological manner. It is mostly applied after musculoskeletal soft tissue trauma or after semi-elective musculoskeletal surgery such as arthroplasty, with ambiguous results. In two studies with total knee arthroplasty (TKA) patients, CFCT reduces postoperative pain and postoperative blood loss, while others found no apparent effect [10], [11], [12], [13]. In total hip arthroplasty (THA) patients CFCT reduces morphine consumption and mitigates postoperative haemoglobin decline, while others demonstrated a shortening of admission time [14], [15], [16]. A hip fracture is generally accompanied by soft tissue trauma that is aggravated by subsequent surgical fixation [17]. As hip fracture patients have duplicate trauma (the fracture and the surgical fixation), experience severe pain, and have fracture site bleeding with related inflammation, these patients are expected to benefit most from CFCT.
To date no studies have researched the efficacy of CFCT in the acute postoperative recovery phase of hip fracture surgery. We aimed to determine the analgesic efficacy of CFCT in the acute postoperative recovery phase of hip fracture surgery. Secondly, we aimed to determine the effect on postoperative blood loss, short-term functional outcome parameters, and assess feasibility. We hypothesized that: 1) CFCT will lower perceived pain levels and analgesic use; and 2) will reduce postoperative blood loss and transfusion incidence; and 3) reduced pain by CFCT will lead to lower delirium incidence, and 4) will enhance functional recovery, leading to shorter LOS.
Section snippets
Methods
The Medical Ethical Committee ‘METC Noord-Holland’, Alkmaar, The Netherlands (date: September 29, 2014; reference no: M014-013) approved the study and after written informed consent was obtained, 126 subjects were enrolled in this open-label, parallel, multicentre, randomized controlled, clinical superiority study within 14 months’ time (December 2014 and January 2016) at eight orthopaedic surgery, general surgery and/or geriatric departments in four hospitals. The study was registered at
Results
Sixty-one subjects in the control group and 64 subjects in the CFCT group received the allocated treatment, and were analysed (Fig. 1). Both groups had similar demographic characteristics (Table 2).
The CFCT group received an average of 9.1 treatments during the first 72 h, and in the control group an average of 9.6 NRS pain scores was registered within the same period. NRS pain was comparable between groups at 24 h, 48 h and 72 h when analysed by the LOCF method (Table 3). The sensitivity analyses
Discussion
No clinical difference in analgesic use, postoperative haemoglobin change, transfusion incidence, functional outcome, LOS, delirium incidence, haloperidol use, location of rehabilitation, and patient-reported health outcome was found between the CFCT and control group. At 72 h, pain, as measured by NRS, was significantly less suggesting that CFCT may have an advantage at 72 h for postoperative pain, but has no added value in the direct postoperative recovery phase of hip fracture. Since subjects
Acknowledgements
We thank Inger Sierevelt for her assistance with data analysis. The cryocompression devices were sponsored by Best Medical Recovery systems (Abcoude, The Netherlands) and were returned after the study ended. ‘Achmea Zorgverzekeringen’ (grant number: Z557) and ‘DSW Zorgverzekeringen’ (grant identifier: GRAPES) funded the study. The funding covered meetings, IRB application costs and CFCT treatment by nurses only. None of the authors received funding from the study. The sponsors had no
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