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Introduction
The efficacy and safety of sterile water injections to manage labour back pain was
demonstrated in recent clinical trials. Varying the number of injections used in the
procedure from four to two has been cited as a means of possibly reducing the injection
pain while maintaining analgesic effect. However, it is not known if the pain relief
provided by two sterile water injections is the same as that from the usual four injections,
or if fewer injections results in a decrease in injection discomfort.
Aim
The aim of this trial was to determine if the pain relief experienced by participants
receiving two water injections would be clinically equivalent to four.
Methods
We conducted a multicenter randomised controlled equivalence trial in which 238 women
in labour with a Visual Analogue Scale pain score (VAS) of 70 millimetres (mm) (0=
no pain; 100= worst pain imaginable) were randomised to two or four sterile water
injections. The primary outcome was pain measured on a VAS at 30 minutes post treatment. A clinically relevant a-priori margin of equivalence was set
at ±10 mm difference in VAS scores. Secondary outcomes included the likelihood of achieving
an at least 30% and 50% reduction in pain, birth and neonatal outcomes.
Results
Clinical equivalence was not demonstrated. Both techniques achieved an at least 30%
reduction in pain in over 75% of participants though duration of effect was longer
in the four injection group. There was no difference in other birth related secondary
outcomes.
Conclusion
Four injections provided a margin of benefit over two injections in level and duration
of analgesia. Four injections remains the technique of choice though two injections
still provided significant pain relief and would be suitable where it was not possible
or desirable to provide four.
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Copyright
© 2022 Published by Elsevier Inc.
