Femoral 3 in 1 RCT
Femoral 3 in 1 RCT
Femoral 3 in 1 RCT
Alan K. Fletcher, MRCP(UK) Study objective: We determine whether 3-in-1 femoral nerve block is effective as
Alan S. Rigby, MSc analgesia for fractured neck of femur when administered by emergency physicians.
Francis L. P. Heyes, FRCS
Methods: This was a prospective, randomized controlled trial with blinded asses-
From the Department of Emer- sors conducted in a district general hospital emergency department in the United
gency Medicine, Rotherham Kingdom. Over a 6-month period, all patients with fractured neck of femur were con-
General Hospital, Rotherham,
United Kingdom (Fletcher, sidered for study. Patients were randomly assigned to receive 3-in-1 nerve block with
Heyes), and the Department of bupivacaine plus intravenous morphine or intravenous morphine. An accreditation
Statistics, University of package for all ED medical staff was devised to ensure competence in the technique
Sheffield, Sheffield, United
of 3-in-1 nerve block. Pain scores were recorded on arrival and at intervals up to 24
Kingdom (Rigby).
hours after admission. Morphine consumption in the first 24 hours was recorded.
Results: Ninety-four patients sustained fractured neck of femur during the study
period; 50 were studied. Of 44 not studied, 42 were confused, 1 did not consent, and 1
was overlooked. Patients receiving 3-in-1 nerve blocks recorded a faster time to
reach the lowest pain score: 2.88 hours for patients with nerve block and 5.81 hours
for control patients (mean difference –2.93 h; 95% confidence interval [CI] –5.48 to
–0.38 h). Nerve block recipients required significantly less morphine per hour than
control patients (mean of 0.49 mg/h versus 1.17 mg/h; mean difference –0.68 mg/h;
95% CI –1.23 to –0.12 mg/h).
Conclusion: Three-in-one femoral nerve block is an effective method of providing
analgesia to patients with fractured neck of femur in the ED. All grades of medical
staff were able to apply and consolidate this skill.
[Ann Emerg Med. 2003;41:227-233.]
M AT E R I A L S A N D M E T H O D S
showed that key safety and technical points had been hourly until analgesia was achieved). This prescription
achieved and when the supervised patient nerve block continued until surgery. Patients in the second group
was considered safe and satisfactory. As all physicians received a 3-in-1 femoral nerve block with 20 mL of
achieved competence, it was possible to consider all 0.5% plain bupivacaine. This was performed by using
patients with all types of fractured neck of femur for the technique described by Winnie et al7; a 21-gauge
this study. Patients who were confused (and therefore needle without a peripheral nerve stimulator was used
unable to give informed consent), had a bleeding instead of a nerve block needle for convenience and
diathesis or were taking warfarin, had local or systemic practicality. Aseptic technique was observed, and
infection, or had previous hypersensitivity to local patients were monitored with ECG and basic observa-
anesthetics were excluded (Figure 2). tions. An intravenous cannula was sited before nerve
Informed consent was obtained once fracture was block in all cases, and its patency was confirmed. The
confirmed with radiography, and patients were ran- femoral pulse was palpated, and the nerve block was
domly assigned to 1 of 2 groups. Patients in the first inserted 1 cm lateral to the pulse once paresthesias were
group were control patients and received analgesia in elicited to localize the nerve. The local anesthetic was
the conventional fashion for our district general hospi- injected in a cranial direction and with pressure distal
tal (ie, 5 to 10 mg of intravenous morphine, available to the needle during and shortly after injection to
encourage the local anesthetic to track cephalad. If
patients required analgesia before radiography, they
Figure 2. received incremental doses of intravenous morphine.
Study flow diagram. Sample size was estimated by using the method
described by Altman8 from data of previously published
studies and from 10 pilot patients in whom a pain score
90 patients with reduction of 50% was observed. We calculated that a
fractured neck of femur
42 excluded because total study size of 50 patients would be required to
of confusion
1 patient refused consent achieve 80% power to observe a 40% pain reduction
1 patient overlooked score difference at the 0.05 significance level. A pilot
50 patients included study indicated that approximately half of all patients
with fractured neck of femur would be ineligible be-
cause of confusion, and this was allowed for in assess-
ment of study feasibility. The data from the pilot study
26 randomized to receive
24 randomized to 3-in-1 femoral nerve are not included in the results. The randomization
receive IV block with 20 mL of
morphine 0.5% bupivacaine
sequence was derived from a random number genera-
tor, and allocation concealment was achieved by means
of the sealed opaque envelope method.
Pain on movement was assessed by using a numeric
Pain scores at rating scale that has been adopted as a hospital standard
0, 1, 4, 8, 12, 16, and 24 h
Morphine consumption at 24 h for measuring pain, ensuring that scores were repro-
ducible. This pain scale has been validated before.9,10
We decided to adopt a numeric rating scale instead of a
Complications and visual analog scale partly because of the difficulties we
mortality recorded
after case note encountered with patient comprehension of visual ana-
review at 6 mo
log scales in the pilot study. Pain was graded as 0, 1, 2, or
3 corresponding to no pain, mild pain, moderate pain,
or severe pain, respectively. Pain on movement was problem of correlation over time and also allow for
assessed on arrival (ie, before randomization) and at 1, missing values (at one or more time points) to be taken
4, 8, 12, 16, and 24 hours after randomization. These into consideration. Thus, the data on pain scores, pulse
assessments were made by ward nursing staff blinded to rate, oxygen saturation, and respiratory rate were ana-
the intervention and formed part of regular nursing lyzed by calculating the area under the curve (essen-
observations undertaken at these times according to the tially a weighted mean) after adjusting for baseline val-
hospital’s fractured neck of femur protocol. With these, ues in an analysis of covariance. However, much of the
records were also made of blood pressure, pulse rate, data at 24 hours were not recorded, and therefore, this
respiratory rate, and oxygen saturation. If measure- time point was excluded from our analyses. Missing
ments did not exactly coincide with time intervals, they data at earlier time points were minimal and were incor-
were assigned to the closest standard time. The admit- porated as truncated means. For the pain score data,
ting orthopedic senior house officer was also unaware another summary measure (time to best response; ie,
of study intervention, and therefore, analgesic prescrip- time at which the lowest pain score was reached) was
tion (although standard at Rotherham) was not influ- also calculated.
enced by patient allocation. Patients were not blinded Results are presented as mean differences with 95%
to group allocation because our research ethics com- confidence intervals (CIs) for the differences. The
mittee considered placebo injection unacceptable. Generalized Linear Interactive Modeling (GLIM; Royal
The same blinded observer (AKF) abstracted all data. Statistical Society, London, United Kingdom) statistical
The total dose of morphine in the first 24 hours after computer package was used for the statistical calcula-
admission or until surgery (if this was sooner), the type tions. A nominal level of 5% statistical significance was
of fracture, and the time to surgery were recorded. This used throughout.
dose included morphine given to patients before radiog-
raphy. Hospital notes were examined again at 6 months R E S U LT S
when the incidence of postoperative complications,
time to discharge, and death rate were recorded. All data The characteristics of the 2 patient groups are given in
were compiled into a Microsoft Excel (Microsoft Table 1. All but 1 (consultant) of the 14 ED medical staff
Corporation, Redmond, WA) spreadsheet before the performed nerve blocks. No one physician or grade per-
study code was deciphered. formed more than 5 nerve blocks, and no clinically
The statistical analysis is concerned with the mea- important variations were seen in nerve block efficacy
surement of serial data (ie, repeat observations made at between physicians. Among the study patients, none
baseline and 1, 4, 8, 12, 16, and 24 hours after random- experienced adverse effects as a result of nerve block
ization). A potential problem with serial data is correla-
tion between subsequent measurements. The statistical
methods adopted to overcome this problem are out- Table 1.
Patient characteristics.
lined by Mathews et al,11 who suggest that serial data
should be analyzed with the “method of summary mea-
Study Patients Control Group
sures.” The method considers the individual patient as Variable (N=24) (N=26)
the basic unit of assessment and constructs 1 or 2
numeric values that best summarize the patients’ Mean age, y (SD) 76 (13) 80 (9)
Female sex, No. (%) 17 (71) 18 (69)
response curve. Thus, for each variable, 1 or 2 impor- Intertrochanteric, No. (%) 15 (63) 15 (58)
tant summary features are calculated per patient, and Subcapital-transcervical, No. (%) 9 (37) 11 (42)
Mean time to surgery, h (SD) 29.3 (20.8) 27.4 (16.5)
these summary features are then analyzed as if they Mean pain score on arrival (SD) 2.8 (0.4) 2.7 (0.6)
were the raw data. Summary measures do not have the
administration. Patients receiving 3-in-1 nerve blocks inflammatory drugs: one in the study group and the
recorded a faster time to reach the lowest pain score other in the control group. No other forms of analgesia
(Figure 3), and nerve block recipients required signifi- (eg, mechanical traction or anxiolytic drugs) were
cantly less morphine per hour than control patients used. Morphine dose is presented as dose per hour
(Figure 4). Analgesia was required initially by virtually because some patients underwent surgery less than 24
all patients, and if this was given before radiography, it hours after admission. Morphine consumption was
has been included in the total dose. All patients were only included up to 24 hours after admission for those
prescribed morphine for pain; one patient initially who underwent surgery later because we believed the
received diamorphine, and this dose was translated to nerve block could realistically only be expected to have
an equivalent morphine dose. Only 2 patients received an effect up to 24 hours after administration.
additional analgesia in the form of nonsteroidal anti- There were no clinically important differences be-
tween the groups in respect to pulse rate, oxygen satu-
ration, or respiratory rate at any time interval (Table 2).
At 6 months’ follow-up, 3 study patients and 3 control
Figure 3.
Mean pain score: time to best response (mean difference [95% patients had died. At 6 months, note review identified 2
CI]: –2.93 h [–5.48 to –0.38 h]). lower respiratory tract infections in study patients and
4 in control patients. One patient in each group had a
deep vein thrombosis on the same side as the fracture
7
(and nerve block).
6
5
DISCUSSION
Time (h)
4
3
We show that 3-in-1 femoral nerve block is effective in
2
producing analgesia in the ED for patients with frac-
1
tured femoral neck. Analgesia is achieved substantially
0
No block 3-in-1 nerve block quicker in patients receiving the nerve blocks, and
these patients require less morphine, reproducing the
Figure 4. Table 2.
Mean morphine dose per hour (mean difference [95% CI]: Three-in-one femoral nerve block randomized controlled
–0.68 mg/h [–1.23 to –0.12 mg/h]). trial: Analysis of serial measurements.*
Mean Mean
1.4 No Difference Difference
Block Block (95% CI), (95% CI),
1.2
Morphine dose/h (mg)
findings of other studies. This has many potential on the orthopedic ward might have been biased if
advantages for patient care, and above all, our data patients revealed their group allocation to them. We
show that the 3-in-1 nerve block technique can be gen- believe this is unlikely because the recorded observa-
erally applicable. The frequency of admissions of tions form part of normal assessment and patients
patients with fractured neck of femur was sufficiently would not draw attention to group allocation in the ED
high to ensure that the practical skills acquired were to either the patient or the nurse. It is possible that the
used enough to permit continued familiarity and confi- nerve blocks worked earlier than the times given
dence among junior physicians. because we did not take more frequent pain measure-
Patients with fractured neck of femur are often in ments during the early period after randomization.
considerable pain, which, if inadequately controlled, Although orthopedic house staff might have identified
might contribute to increased morbidity by reducing patients with nerve block after neurologic examination
mobility and increasing anxiety and confusion. In the on the ward, they were not responsible for recording
ED, the management of pain in these patients centers pain scores and were bound by a protocol morphine
on the administration of parenteral morphine, which prescription. We would emphasize that in undertaking
itself has attendant disadvantages, such as respiratory this pragmatic study, we set out to establish whether
depression and increased confusion, in particularly this local anesthetic technique would be feasible and
susceptible elderly patients. Apart from obvious effective in a district hospital ED. Studies have shown
humanitarian reasons for seeking adequate analgesia, numeric rating scales to be on par with visual analog
there are therefore sound clinical reasons why effective scales, with target scores of 0 or 1 corresponding to no
and safe analgesia for fractured neck of femur is in our pain or mild pain. All our patients achieved either of
patients’ best interest. these targets eventually (their best pain score).
A best practice review of the care of patients with A peripheral nerve stimulator was not used because
fractured neck of femur included a femoral nerve block our aim was to apply the nerve block technique to a typ-
as analgesia in the ED.12 This is not common practice, ically busy ED, where such items of equipment fre-
and evidence in support of its use is sparse. Three pub- quently are misplaced and are time-consuming to use.
lished studies have described the successful use of Despite improvement in pain scores and morphine con-
femoral nerve block or 3-in-1 femoral nerve block in sumption, there were no significant effects on physio-
this situation.4-6 All studies relied on experts to admin- logic parameters or complications after nerve block.
ister the block, 2 had no control patients,5,6 and 1 in- Such parameters are influenced by many factors, and
cluded some young patients (mean age, 68 years) in a differences were not expected in this study, which was
study population that was not clearly defined.7 Our powered to examine the effect on pain scores and mor-
study examines the applicability of 3-in-1 femoral phine consumption. Similarly, this study was not pow-
nerve blocks in a district general ED in which admitted ered to examine safety of the block, and although no
patients with fractured neck of femur might present at adverse events occurred, it is important that clinicians
any time and on any day and are assessed and initially are aware of potential problems, such as inadvertent
managed by junior physicians with hitherto little expe- intravascular injection, infection, intraneural injec-
rience of regional anesthesia. tion, and masking compartment syndrome. To our
Study limitations include the fact that patients were knowledge, the latter has only been described very
not blind to group allocation for ethical considerations. rarely and confined to epidural anesthesia and lower leg
We believe, however, that the placebo effect alone could fractures.13,14
not account for such marked differences between the It is important to be aware that injection of a large
groups when the distraction of pain and circumstance volume of bupivacaine in the close proximity of blood
was considerable. It is conceivable that nurse assessors vessels is not without risk of serious adverse effects,
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