Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus limb elevation

doi:10.21203/rs.3.rs-3960693/v1

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Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus limb elevation

https://doi.org/10.21203/rs.3.rs-3960693/v1

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published 03 May, 2024

Read the published version in Journal of Orthopaedic Surgery and Research →

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Background

Tourniquets are common adjuncts in the operating theatre but can be associated with post-operative pain. This study was designed to compare what effect pre-tourniquet Esmarch bandage exsanguination has on pain, compared to pre-tourniquet exsanguination by elevation alone.

Methods

52 volunteers (104 lower limbs) were included in this study with each volunteer acted as their own matched control. The primary outcome was pain level, measured in both legs simultaneously using visual analogue scale every 2 minutes for 20 minutes of tourniquet inflation and every minute after deflation. Secondary outcomes were pain difference, cumulative pain score, time of recovery and blood pressure during occlusion and release time.

Results

There was no statistically significant difference in cumulative pain score between legs regardless dominance, site of investigation and point of time. There was no difference in cumulative pain scores between Esmarch and elevation under inflation (50.6, SD 17.0 vs 51.7, SD 16.8, p = 0.87) or deflation (23.4, SD 14.8 vs 24.1, SD 14.9, p = 0.94). Time to full recovery of the lower limb was the same for both groups — 7.6 minutes (SD 2.1min, p = 0.80).

Conclusion

Previous studies describe a positive effect on pain when Esmarch bandage was used prior to tourniquet inflation for upper limb. Using a high level of evidence, we could not prove the same benefit from Esmarch when it was used on lower limbs during inflation of tourniquet, nor after release. These two techniques yield similar pain profiles, and patient factors need to be considered when deciding between elevation and Esmarch bandage.

Tourniquet

pain

lower limb

Dating back to ancient Rome [1], the tourniquet is widely used in upper and lower limb surgeries. Over time, it evolved from a simple hand-tied constricting band to the modern-day pneumatic tourniquet [2]. It restricts blood flow in the operative limb to allow better visualisation of surgical field and prevent excessive blood loss during surgery. However, prolonged tourniquet use is associated with pain, morbidity and mortality [3–7].

Compression from the tourniquet results in ischaemic cascade [8]. Decreased blood flow leads to inadequate oxygen delivery and impaired removal of metabolic waste products, including carbon dioxide and lactate, at the level of the tourniquet and distally [9]. As the result of this process, acidosis develops and progresses to tissue damage with time [10].

Ischaemic pain was found to be less intense if adequate exsanguination of the limb is performed prior to tourniquet inflation [11]. Surgeons are divided on the choice of limb elevation versus exsanguination with a wrapped compressive bandage prior to tourniquet inflation. A clinical trial investigating the difference in pain level between these two methods for the upper limb found that exsanguination was more comfortable for the patient compared to simple elevation above the head, both during the tourniquet inflation period and afterwards in the recovery phase [12].

As of yet, no trials exist comparing methods of exsanguination prior to tourniquet inflation in the lower limb. We aimed to determine whether Esmarch bandage exsanguination or limb elevation before tourniquet application resulted in more discomfort both during inflation and after deflation. Our primary outcome was degree of patient reported pain and secondary outcomes were pain at every 2-minute check, pain score after recovery phase, duration of recovery phase and blood pressure throughout testing.

This study was registered in the Australia and New Zealand Clinical Trials Registry (ACTRN12622000727741p) and ethically approved by the Townsville Hospital & Health Service (HREC/2022/QTHS/80081) to be carried out at Townsville University Hospital and Cairns Base Hospital.

This prospective single-blind randomised control trial involved each participant receiving the intervention (Esmarch bandage exsanguination) and control (limb elevation) measures simultaneously in opposite lower limbs.

Recruitment

The study was conducted in the orthopaedic clinic at Townsville University Hospital and Cairns Base Hospital. Email invitations were sent to Queensland Health staff in both hospitals. One week was allowed for recruitment of study participants via email with information leaflet and consent form attached. A paper copy of the signed consent form was obtained on their day of testing. We aimed to match or exceed the number of participants used in a similar study conducted by Lees et al. on the upper limb – 26 volunteers [12]. The eligibility of participants was determined using the inclusion and exclusion criteria in Table 1. Participants had the opportunity to withdraw from the study at any time.

Table 1

Inclusion and exclusion criteria
Inclusion criteria
Age over 18 years Ability to provide informed consent Attendance for study measurements
Exclusion criteria
Peripheral or central nervous system disorders, including acute or chronic brain pathology, compressive peripheral neuropathy, spinal canal stenosis or nerve root impingement Abnormal power or sensation in lower limbs Medical condition affecting blood supply or sensation of lower limbs such as diabetes, multiple sclerosis, peripheral vascular disease, myocardial infarction, stokes, hypertension, anaemia and preventative medications for whose conditions Any type of lower limb tendinitis Hip, knee or ankle dislocation in past 12 months Previous trauma to hip, knee ankle or foot resulted in deficit muscles power or sensation Thoracic, lumbar or sacral spine osteoarthritis Previous injury, trauma or surgery on thoracic, lumbar or sacral spine History of venous thromboembolism or arterial occlusion Surgical procedure performed on lower limbs in the last 12 months Medications Pharmacological medication, supplements or traditional medicines affecting coagulation profile

[Insert Table 1]

Study methods

A minimum of four participants were scheduled per business day. Data collection occurred over 3 months. No formal long term follow up was required. Full name, age and gender of participants was recorded. Initial pain score based on visual analogue scale (VAS) was recorded, as well as blood pressure and inspection of the skin. Patients were informed of their randomisation via envelope in the clinic room. Once comfortable lying supine on the hospital bed, Softban Orthopaedic Wool (Smith & Nephew, London, United Kingdom) was applied to the limb undergoing Esmarch bandage exsanguination followed by the bandage itself. The other lower limb was elevated to 45° of hip flexion for three minutes. Researchers then changed room for blinding purposes and inflated tourniquets on both thighs to a standard pressure of 300 mmHg. The SmartPump Dual Channel machine will be used as tourniquet (Stryker Pty Ltd, Sydney, Australia, ARTG entry 266269, start date 17/12/2015). VAS score was recorded at baseline and every two minutes until tourniquet is deflated and VAS score returned to baseline. The tourniquet was deflated either at 20 minutes or when the participant requested this due to abnormal discomfort, whichever came first.

The primary outcome was total pain score after 20 minutes. Secondary outcomes were pain at every 2-minute check, pain score after recovery phase, duration of recovery phase and blood pressure throughout testing. Main potential adverse effects from tourniquet were pain, temporary loss of sensation and/or changes in skin colour below tourniquet, loss of muscle strength during inflation of tourniquet and early after deflation, elevation of blood pressure secondary to pain and bruise at the site of compression.

Statistical analyses

The data is reported as mean ± standard deviation. Q-Q plots and Kolmogorov-Smirnov tests were used to assess normality of outcome distribution. A 2-way (limb x time) repeated measures analysis of variance (ANOVA) was conducted for the pain measures. A one-way repeated measures analysis of variance was conducted for SB, DP and MAP. When an interaction effect, main effect of limb or time was identified, a Bonferroni pairwise comparison was conducted as post-hoc tests. For the cumulative pain levels across the time points, an unpaired t-test was used to compare measures between each limb. The alpha level was set as 0.05 for all tests.

[Insert Fig. 1]

Figure 1 depicts the pain levels for each limb, pain differences between limbs and blood pressure measures during occlusion and release. During occlusion, there were neither interaction effects nor main effects of limb exsanguination method (p > 0.05). However, there was a main time effect, with pain increasing from T0 to T2-T10, and then increasing again from T11-12. Similar trends were found for release, with neither interaction effect nor main effect of limb. However, the pain levels were reversed, with a significant reduction at each time point, until the differences reached a plateau by R10. For blood pressure, there were no main time effects for DP and MAP during occlusion. However, SBP was significantly greater at T2 when compared to T12, T14 and T16 during inflation. During release, there was no main time effect for SBP and DP. However, MAP was significantly greater at R3 when compared to R1.

Table 2 presents the cumulative scores for pain levels for each limb. There were no significant differences between the limbs during occlusion and release when considering cumulative scores and area under pain curve.

Table 2

Mean (SD) cumulative pain scores during inflation and deflation, area under curve and time to full recovery for elevated and Esmarch exsanguinated limbs
	Elevation	Esmarch	p-value
Cumulative scores under inflation	51.7 (16.8)	50.6 (17.0)	0.87
Cumulative scores under deflation	24.1 (14.9)	23.4 (14.8)	0.94
Area under curve	76.10 (2.11)	74.01 (2.09)	0.41
Time until full recovery	7.6 (2.1)	7.6 (2.1)	0.80

[Insert Table 2]

Bandage exsanguination prior to tourniquet inflation for 20 minutes on the lower limb does not significantly improve pain. Cumulative pain scores and area under curve were not significantly different between the Esmarch and elevation groups at any of the time points recorded. Time until full recovery of sensation in the limb was also unaffected by exsanguination method. A similar study conducted on the upper limb has shown that there was a statistically significant improvement in pain with Esmarch exsanguination (p = 0.004) when using the area under curve method of cumulative pain measurement [12].

Scintigraphy has shown that Esmarch bandage reduces regional blood volume in the lower limb by 64% and hence produces a greater exsanguination than limb elevation at 60° for 30 seconds which exhibited a 45% reduction [13]. Furthermore, the same study found that an extended period of limb elevation up to 10 minutes did not significantly change the blood volume reduction (44%) [13]. Angle of limb elevation is important; stasis of the blood in the limb does not occur at 60° [13] but has been shown to occur at 90° due to obstruction of venous outflow [14].

Technique variables play an important role in how tourniquet pain is perceived by the patient. Duration of tourniquet inflation and use of regional anaesthesia has been found to be in direct proportion to pain [15]. However, inflation pressure did not significantly impact the incidence or severity of pain in the same study, regardless of whether the tourniquet was applied to the upper limb or lower limb [15].

Pain aside, there are risks associated with Esmarch bandage use for exsanguination. Skin tension blisters are a documented adverse effect that occurs more commonly with this technique compared to limb elevation [16]. This is due to constant friction generated between the Esmarch bandage and the skin resulting in the accumulation of fluid-filled vesicles underneath the epidermis. They may become complicated with superficial or deep infections [17]. Other events such as wound haematoma, wound ooze, deep vein thrombosis (DVT) and pulmonary embolism (PE) are less common but have similar incidence rates between Esmarch and elevation [16]. Use of Esmarch bandage and tourniquet with subsequent mechanical dislodgement of pre-existing DVT causing PE has been recorded in the literature, with some cases even resulting in death [18–22]. The majority of these are from orthopaedic trauma cases, however some were recorded for elective cases such as total knee arthroplasty (TKR) [19]. In light of this potentially fatal outcome, some authors recommend against the use of Esmarch bandage for exsanguination in TKR [23, 24], knee arthroscopy [24], and trauma cases, particularly where there has been a delay for surgical treatment [18].

One strength of this study is that 52 participants volunteered – the largest study comparing tourniquet-associated pain between Esmarch and limb elevation to our knowledge. The paired design of this study – with patients reporting on pain levels for the two techniques simultaneously on each lower limb – lends greater intra-rater reliability. Furthermore, no surgical procedure was being undertaken at the time which may otherwise induce anxiety in some participants and subsequently affect outcome measurements. Randomisation of left and right lower limbs for exsanguination method was performed to reduce the effect of limb dominance on pain perception. Blinding of researchers was carried out to reduce observer bias.

With the duration of tourniquet inflation being 20 minutes, results from this study are limited in their external validity to relatively short lower limb operations. Local and regional blocks may also be used, such as spinal or epidural block in the settIng of knee arthroplasty, which will augment pain perception from the tourniquet.

This randomized controlled trial investigated of impact of exsanguination technique in the use of surgical tourniquets of the lower limb. Our findings demonstrated that there is no significant difference in pain levels between esmarch use or exsanguination by elevation along. These results suggest that the choice of exsanguination technique prior to tourniquet application can be based on surgeon preference and patient-specific factors, as the two methods demonstrated no significant difference in terms of pain. This study contributes insights into the management of tourniquet-associated pain, a critical aspect of patient care in orthopaedic surgery. Future research could explore additional variables that might influence pain or examine surgical outcomes to further enhance patient care in surgical settings.

The authors declare that they have no conflicts of interest to disclose, no financial interests, and no non-financial interests. No funding was received for conducting this study.

Authors' contributions:

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Alex Mitrichev, John Maunder and Prince Singh. The first draft of the manuscript was written by Alex Mitrichev and Aiden Jabur and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Acknowledgements

The authors would like to thank Kenji Doma and Andrea Grant for their assistance with statistical analysis and presentation of the results.

Disclosure Statement

The authors declare they have no disclosures or conflicts of interest to report. The authors declare that data and materials were analysed by a statistician and published claims comply with field standards.

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No competing interests reported.

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Journal Publication

published 03 May, 2024

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Editorial decision: Revision requested
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You are reading this latest preprint version

Randomised controlled trial of tourniquet associated pain generated in lower limb after exsanguination by Esmarch bandage versus limb elevation

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