A Randomized Controlled Trial of Femoral Nerve Blockade Administered Preclinically for Pain Relief in Femoral Trauma

Schiferer, Arno; Gore, Carmen; Gorove, Laszlo; Lang, Thomas; Steinlechner, Barbara; Zimpfer, Michael; Kober, Alexander

doi:10.1213/01.ane.0000287676.39323.9e

Cited by 40 publications

(55 citation statements)

References 9 publications

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“…It is possible that their high compliance levels can be explained by intensive pre-trial training (the intensive care paramedics required a 16-hour training programme before acceptance onto the trial) and better comprehension of the necessity for a robust, well-conducted study. 37,143 Those trials involving fluid administration, including four of the head-injury trials, to which paramedics were blinded (using identical, randomised fluid bags) and therefore had no control over which interventions they were giving, had compliance levels of over 90%. 139,141 In these cases the paramedics were unaware of which treatments they were administering and were therefore unable to decide to break treatment protocol.…”

Section: Compliancementioning

confidence: 99%

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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BackgroundReconfiguration of trauma services, with direct transport of traumatic brain injury (TBI) patients to neuroscience centres (NCs), bypassing non-specialist acute hospitals (NSAHs), could potentially improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) and the difficulties in reliably identifying TBI at scene may make this practice deleterious compared with selective secondary transfer from nearest NSAH to NC. National Institute for Health and Care Excellence guidance and systematic reviews suggested equipoise and poor-quality evidence – with regard to ‘early neurosurgery’ in this cohort – which we sought to address.MethodsPilot cluster randomised controlled trial of bypass to NC conducted in two ambulance services with the ambulance station (n = 74) as unit of cluster [Lancashire/Cumbria in the North West Ambulance Service (NWAS) and the North East Ambulance Service (NEAS)]. Adult patients with signs of isolated TBI [Glasgow Coma Scale (GCS) score of < 13 in NWAS, GCS score of < 14 in NEAS] and stable ABC, injured nearest to a NSAH were transported either to that hospital (control clusters) or bypassed to the nearest NC (intervention clusters). Primary outcomes: recruitment rate, protocol compliance, selection bias as a result of non-compliance, accuracy of paramedic TBI identification (overtriage of study inclusion criteria) and pathway acceptability to patients, families and staff. ‘Open-label’ secondary outcomes: 30-day mortality, 6-month Extended Glasgow Outcome Scale (GOSE) and European Quality of Life-5 Dimensions.ResultsOverall, 56 clusters recruited 293 (169 intervention, 124 control) patients in 12 months, demonstrating cluster randomised pre-hospital trials as viable for heath service evaluations. Overall compliance was 62%, but 90% was achieved in the control arm and when face-to-face paramedic training was possible. Non-compliance appeared to be driven by proximity of the nearest hospital and perceptions of injury severity and so occurred more frequently in the intervention arm, in which the perceived time to the NC was greater and severity of injury was lower. Fewer than 25% of recruited patients had TBI on computed tomography scan (n = 70), with 7% (n = 20) requiring neurosurgery (craniotomy, craniectomy or intracranial pressure monitoring) but a further 18 requiring admission to an intensive care unit. An intention-to-treat analysis revealed the two trial arms to be equivalent in terms of age, GCS and severity of injury. No significant 30-day mortality differences were found (8.8% vs. 9.1/%;p > 0.05) in the 273 (159/113) patients with data available. There were no apparent differences in staff and patient preferences for either pathway, with satisfaction high with both. Very low responses to invitations to consent for follow-up in the large number of mild head injury-enrolled patients meant that only 20% of patients had 6-month outcomes. The trial-based economic evaluation could not focus on early neurosurgery because of these low numbers but instead investigated the comparative cost-effectiveness of bypass compared with selective secondary transfer for eligible patients at the scene of injury.ConclusionsCurrent NHS England practice of bypassing patients with suspected TBI to neuroscience centres gives overtriage ratios of 13 : 1 for neurosurgery and 4 : 1 for TBI. This important finding makes studying the impact of bypass to facilitate early neurosurgery not plausible using this study design. Future research should explore an efficient comparative effectiveness design for evaluating ‘early neurosurgery through bypass’ and address the challenge of reliable TBI diagnosis at the scene of injury.Trial registrationCurrent Controlled Trials ISRCTN68087745.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 1. See the NIHR Journals Library website for further project information.

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Section: Compliancementioning

confidence: 99%

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Lecky

Russell

Fuller

et al. 2016

Health Technol Assess

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“…There is sufficient data to show the usefulness of FNB to relieve pain from fracture of the femur and now, is being used for positioning during central neuraxial blockade as well. 3,4,12,[19][20][21][22] Femoral nerve block can be performed using peripheral nerve stimulator, ultrasound guided technique or by loss of resistance technique. Geier KO concluded that there were no significant differences regarding efficiency between loss of resistance and peripheral nerve stimulator methods.…”

mentioning

confidence: 99%

Positioning for regional anesthesia in femur fracture surgeries: how effective is femoral nerve block? a randomised control study

Purohit¹,

Sireesha²,

Badami³

2017

Int J Res Med Sci

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Background: Fracture of the femur is a common orthopaedic problem following trauma in patients of all ages. This study was undertaken to evaluate the effectiveness of femoral nerve block (FNB) in positioning the patients for regional anesthesia.Methods: 100 patients between the ages 18 to 80 years, of ASA grade I, II and III, scheduled for elective surgeries of femur fracture were evaluated in 2 groups. Group FNB (n=50) received femoral nerve block with 15ml of 1.5% lignocaine and Group. Non FNB (n=50) was not given any block. Assessment of pain was carried out using visual analog scale (VAS). This was rated before, during and after the procedure of positioning for spinal/combined spinal epidural anesthesia (CSE). Vital parameters were tabulated.Results: VAS scores were noted at 0, 2, 5,10,15 minutes and at the time of positioning. VAS scores at 15 minutes after FNB was 1.473 ±0.1639 and 8.250±0.3615 in patients without FNB. Time taken for CSE was significantly less in FNB group (13.026±0.4628) minutes as compared to non FNB group (19.660 ±0.3742) minutes. Patient satisfaction scores were significantly higher in FNB group (45/50) 1.4952±0.033 as compared to non FNB group (10/50) 0.3460±0.1786. Quality of patient positioning was better in FNB group (2.782 ±0.1273) as compared to non FNB (1.382±0.2473).Conclusions:This study concludes that FNB is highly effective in giving good pain relief for positioning for regional anaesthetic procedures improving performance time and offers higher acceptance among patients with femoral fractures.

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“…13 The use of femoral nerve block to relieve pain is now frequently being used during spinal anathesia. [17][18][19] In our study, we found the femoral nerve blocker, lignocaine to be significantly better than fentanyl for the positioning of the hip for surgery with the VAS scores being significantly lower. This was found to be in accordance in other similar studies.…”

Section: Discussionmentioning

confidence: 51%

Comparative study of efficacy of femoral nerve block and IV fentanyl for positioning during femur fracture surgery

Reddy

Rao²

2016

Int Surg J

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A Randomized Controlled Trial of Femoral Nerve Blockade Administered Preclinically for Pain Relief in Femoral Trauma

Abstract: Preclinically administered femoral nerve blockade effectively decreases pain, anxiety, and heart rate after femoral trauma. Regional blockade is an option for out-of-hospital analgesia administered by a trained physician.

Cited by 40 publications

References 9 publications

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

The Head Injury Transportation Straight to Neurosurgery (HITS-NS) randomised trial: a feasibility study

Positioning for regional anesthesia in femur fracture surgeries: how effective is femoral nerve block? a randomised control study

Comparative study of efficacy of femoral nerve block and IV fentanyl for positioning during femur fracture surgery

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