1. DR. DE IS M RIZAL CHAIDIR., DR., SPOT(K)., M.KES(MMR).,
M.H.KES
DR. NUCKI NURSJAMSI HIDAJAT., DR., SPOT(K)., M.KES
WIDYA ARSA., DR., SPOT(K)., CCD
RAMCO ATIZA, DR.
2. Introduction
Tourniquets are routinely used to provide a dry surgical field for both elective and trauma
procedures: their prolonged application can be associated with increased discomfort, morbidity
and mortality
The direct compressive effects of a tourniquet have been implicated in the development of local
pain.
More global limb pain may, however, be the result of noxious metabolites and free radicals
generated by its application.
It has previously been suggested that exsanguination of the limb delays the accumulation of
these agents and is less painful for the conscious patient
3. Problem
There are currently no clinical studies which compare limb exsanguination to elevation before
the tourniquet is inflated and their subsequent impact on the patient’s level of discomfort.
4. Aims
The purpose of this study was to determine whether exsanguination of the upper limb before
inflation of a tourniquet produces a lower level of patient-reported pain than elevation
5. Patients and Methods
• Prospective single-blind randomized controlled trial
• Population : 107 volunteers
• Exclusion : 54 volunteers
• Sample : 26 volunteers (based on their availability for the dates on
which the study was to be performed)
• Right handed : 20 volunteers, Left handed : 6 volunteers
• Average age : 37,7 y.o. (range : 23 – 58)
9. Outcome measure
The primary outcome measure was the total pain experienced by each volunteer while the
tourniquet was inflated for 20 minutes, calculated as the area under the pain curve for each
patient.
Secondary outcomes were pain VAS at each time point; the total pain experienced during the
recovery phase; the ability to tolerate the tourniquet and the time for full recovery to occur
after deflation of the tourniquet.
10. Randomisation
This was carried out using sealed envelopes, which were opened once the tourniquet had been
applied but not inflated.
Patients were randomised into two groups; Group A (13 patients): dominant arm exsanguinated
and non-dominant arm elevated and Group B (13 patients): non-dominant arm exsanguinated
and dominant arm elevated.
Therefore in total 26 arms underwent exsanguination and 26 underwent elevation
11. Blinding
Once the subject had been prepared and the tourniquets inflated, the randomisation envelopes
were resealed and the researchers swapped rooms.
They therefore completed the outcome measurements on a subject they had not prepared,
blinding them to the allocation of treatment
12. Statistical analysis
Primary outcome two patients who requested early deflation were excluded as the area under
the pain curve to 20 minutes could not be calculated (n = 24).
All other analyses included the complete study cohort (n = 26) except for the comparisons of
pain VAS at the 14 minute time point (n = 25), and at 16, 18 and 20 minute time points (n = 24)
again because of loss of patients owing to early tourniquet deflation.
Statistical analysis was performed using MINITAB 17 software
13. RESULTS
The main area under the pain : 94,5
The main area under the recovery curve : 15,0
The median time to recovery after deflation of the tourniquet : 6 mnt
14. Exsanguination and elevation groups
The mean pain VAS at each time point for
both the exsanguination and elevation
groups can be seen in Figure 2a.
There was a significant difference using
the paired student’s t-test in the area
under the pain curves in favour of
exsanguination (mean difference = 8.4,
95% confidence intervals (CI) 3.0 to 13.7,
p = 0.004)
15. Dependent upon hand dominance
Analysis of the pain curves by dominance of
the arm showed there was no difference
between the dominant and non-dominant
arms (mean difference = -0.2 (95% CI -23.2 to
22.8, p = 0.99 paired Student’s t-test)
16. Results
•24 patients tolerated tourniquets for 20 mnts
•1 patient requested deflation < 16 mnt
•1 patient requested deflation < 14 mnt
•The area under the recovery curves were similar for both the exsanguination and elevation
groups (mean difference 0.7; 95% CI -6.0 to 4.6, p = 0.78)
•no statistical difference for the median time for taken for full recovery to occur: recovery took
0.5 minutes (30 seconds) longer in the elevation group (p = 0.06, Wilcoxon test)
•The maximum reported pain score for both groups was 9.9.
17. Mean difference in pain VAS
Comparisons of the mean pain score at each time
point showed significant differences which
favoured exsanguination at 14 minutes (mean
difference 0.6; 95% CI 0.2 to 1.1, p = 0.009 paired
Student’s t-test) and 16 minutes (mean difference
0.6; 95% CI 0.1 to 1.1, p = 0.02 paired Student’s t-
test)
During the inflated phase, and at two minutes
(mean difference 0.6; 95% CI 0.1 to 1.2, p = 0.03
paired Student’s t-test) and four minutes (mean
difference 0.2; 95% CI 0.0 to 0.4, p = 0.04 paired
Student’s t-test) during the recovery phase
18. Mean heart rates
The heart rate of patients increasedsignificantly
(p < 0.001 paired Student’s t-test) throughout
the inflation stage from a mean baseline of 69
bpm (95% CI 65 to 73) to a maximum of 90 bpm
at 20 minutes (95% CI 86 to 94).
Heart rate then returned to baseline during the
recovery phase, usually by the sixth minute after
deflation of the cuff (Fig. 2d).
After application and inflation of the
tourniquets, it was noted that there was a
marked difference in colour between the two
arms, the exsanguinated arm being visibly paler
compared with the elevated and more cyanosed
arm
19.
20. Discussion
Patients who have an upper arm tourniquet inflated for 20 minutes experience less pain if the
limb is exsanguinated than those who simply have the arm elevated.
Function and sensation typically recover a median of 30 seconds sooner in patients who have
the limb exsanguinated.
21. Discussion
The primary analysis was based on the total pain experienced during an inflation period of 20
minutes. The comparison of the area under the pain curve only became significant at 18 minutes
and for individual time-point comparisons, the first significant difference was seen at 14
minutes.
We cannot therefore make generalisations about the benefit of exsanguination in situations
where the expected inflation time is shorter than this.
22. Discussion
Scintigraphic techniques have clearly shown that exsanguination reduces the blood volume in
the limb significantly more than elevation.
It has been suggested that if blood is expressed from the arm before the tourniquet is applied,
patients may not experience ischaemic pain for 30 to 45 minutes, Dushoff has suggested that
this figure could be extended to 75 minutes.
The aim of this study was not to study maximum tolerance times, but rather the difference in
levels of comfort during a period of time similar to that required for routine upper limb
procedures e.g. Dupuytren’s fasciectomy or carpal tunnel decompression (CTD).
23. Discussion
Our analysis reveals significantly less discomfort in the exsanguination group at 14 (p = 0.009)
and 16 minutes (p = 0.02): these may be times close to the end of the procedure where
meticulous inspection and closure may be instrumental to the success of the procedure and a
calm, motionless patient is important
24. Limb reperfusion pain has also been clearly described. This occurs after tourniquet deflation
when blood flow is restored and toxic metabolites removed.
Our results show a faster recovery in the exsanguination group with significant differences at
two and four minutes (p = 0.04, for both intervals).
The exsanguination group took a median time of 30 seconds less than the elevation group to
achieve full recovery, but this was not statistically significant (p = 0.06).
The recovery graphs show an initial sharp reduction in pain, followed by a slower progression to
full recovery.
All of the volunteers reported a very intense sensation of ‘pins and needles’ during the recovery
period. This was associated with visible hyperaemia of both arms, which many described as
almost worse than the discomfort of the tourniquet, but which passed very quickly
25. A comprehensive background literature search found that a number of studies have assessed
different variables related to the use of tourniquets.
Tourniquet types (pneumatic vs silicone ring design), high arm versus forearm, and lower limb
tourniquet tolerances have all been compared. Patient satisfaction with procedures that use
tourniquet and local/regional anaesthetic have also been studied.
These have shown overall good rates of satisfaction, provided that the tourniquet-related
discomfort was well tolerated.
In keeping with our design, these studies used volunteers as a control and a VAS was used to
assess pain levels.
All these studies exsanguinated the limbs and tourniquet inflation time was limited to less than
30 minutes, again, consistent with our design.
26. A noticeable rise in blood pressure has also been associated with increasing discomfort from the
tourniquet.
As both arms were being used simultaneously in this study, blood pressure could not be
monitored, so pulse rate was used as a surrogate for the physiological response to pain. The
pulse rate increased proportionally throughout the duration of the inflation period, but then
rapidly returned to baseline during the recovery period.
It was interesting to note that in some cases, where recovery of normal sensation took longer
than six minutes, the heart rate dipped below the recorded baseline, possibly hinting at some
pre-intervention anticipation anxiety.
Return to normal sensation and full function after deflation of the tourniquet was less than ten
minutes for all subjects.
27. Conclusion
The results of this study suggest that exsanguinating the upper limb before inflating the
tourniquet may be better than elevating the arm in terms of tourniquet pain and recovery time
for surgical procedures under a local or regional block.