A comparison of two versus four sterile water injections for the relief of back pain in labour: A multicentre randomised equivalence trial |
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| Affiliation: | 1. School of Nursing Midwifery and Social Work, University of Queensland, Level 3 Chamberlain Building, St Lucia, Queensland, Australia;2. Central Coast Local Health District, Holden Street, Gosford, NSW 2250, Australia;3. North Sydney Local Health District, Coronation Street, Mona Vale, NSW 1660, Australia;4. School of Health Sciences, University of Skovde, Box 408, SE541 28, Sweden;5. Molly Wardaguga Research Centre, College of Nursing & Midwifery, Charles Darwin University, Level 11, East Building, 410 Ann St, Brisbane, Queensland, 4000, Australia;1. Australian Centre for Public and Population Health Research (ACPPHR), School of Public Health, Faculty of Health, University of Technology Sydney, PO Box 222, Jones St, Ultimo, 2007 NSW, Australia;2. Institute for Sustainable Futures, University of Technology Sydney, PO Box 222, Jones St, Ultimo, 2007 NSW, Australia;3. School of Nursing and Midwifery, Western Sydney University, Locked Bag 1797, Penrith, 2751 NSW, Australia;1. School of Midwifery, College of Medicine and Health Science, University of Gondar, Gondar, Ethiopia;2. Department of Epidemiology and Biostatistics, Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia;3. Department of Women’s and Children’s Health, Division of Reproductive Health, Karolinska Institute, Sweden;4. Department of Public Health, College of Health Science, Debre Berhan University, Debre Berhan, Ethiopia;5. Department of Midwifery, College of Health Science, Debre Berhan University, Debre Berhan, Ethiopia;1. University College South Denmark, Degnevej 16, 6705 Esbjerg Ø, Denmark;2. University of Southern Denmark, Department of Clinical Research, Winsløwparken 19, 5000 Odense, Denmark;3. Aarhus University Hospital, Unit for Perinatal Loss, Palle Juul-Jensens Blvd. 99, DK- 8200 Aarhus N, Denmark;4. University of Southern Denmark, Department of Public Health, J.B. Winsløwsvej 9B, 5000 Odense, Denmark;1. Judith Lumley Centre, La Trobe University, Bundoora, VIC 3086, Australia;2. School of Nursing & Midwifery, La Trobe University, Bundoora, VIC 3086, Australia;3. The Royal Women’s Hospital, Locked Bag 300, Cnr Grattan St and Flemington Rd, Parkville, VIC 3052, Australia;1. CNHS, Flinders University, Australia;2. Arctic University of Norway, Rural and Remote Arctic Health, Campus Hammersfest, Norway |
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| Abstract: | BackgroundRecent trials demonstrated the safety and efficacy of sterile water injections to provide relief from labour back pain. While four injections is the most common approach variations in technique, such as employing two injections, are also used.AimTo determine if the analgesic effect of two sterile water injections is clinically equivalent to four.Methods238 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 min post treatment. A priori margin of equivalence was set at ±10 mm. Secondary outcomes included the likelihood of achieving an at least 30% and 50% reduction in pain, birth and neonatal outcomes.ResultsAt 30 min post-injection the difference in VAS scores between the techniques was ?5.97 (95% Confidence Interval [CI] ?13.18–1.22). As the lower end of the CI exceeds the margin of ?10 mm 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.ConclusionFour injections provided a margin of benefit over two injections in level and duration of analgesia.DiscussionFour 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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| Keywords: | Water injections Natural childbirth Back pain Midwifery Pain management |
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