A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour

Lee, Nigel, Coxeter, Peter, Beckmann, Michael, Webster, Joan, Wright, Vanessa, Smith, Tric and Kildea, Sue (2011) A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour. BMC Pregnancy and Childbirth, 11 21: 1-9. doi:10.1186/1471-2393-11-21


Author Lee, Nigel
Coxeter, Peter
Beckmann, Michael
Webster, Joan
Wright, Vanessa
Smith, Tric
Kildea, Sue
Title A randomised non-inferiority controlled trial of a single versus a four intradermal sterile water injection technique for relief of continuous lower back pain during labour
Journal name BMC Pregnancy and Childbirth   Check publisher's open access policy
ISSN 1471-2393
Publication date 2011-03-23
Sub-type Article (original research)
DOI 10.1186/1471-2393-11-21
Open Access Status DOI
Volume 11
Issue 21
Start page 1
End page 9
Total pages 9
Place of publication London, U.K.
Publisher BioMed Central
Collection year 2012
Language eng
Formatted abstract
Background: Almost one third of women suffer continuous lower back pain during labour. Evidence from three systematic reviews demonstrates that sterile water injections (SWI) provide statistically and clinically significant pain relief in women experiencing continuous lower back pain during labour. The most effective technique to administer SWI is yet to be determined. Therefore, the aim of this study is to determine if the single injection SWI technique is no less effective than the routinely used four injection SWI method in reducing continuous lower back pain during labour.

Methods/design: The trial protocol was developed in consultation with an interdisciplinary team of clinical researchers. We aim to recruit 319 women presenting at term, seeking analgesia for continuous severe lower back pain during labour. Participants will be recruited from two major maternity hospitals in Australia. Randomised participants are allocated to receive a four or single intradermal needle SWI technique. The primary outcome is the change in self-reported pain measured by visual analogue scale at baseline and thirty minutes post intervention. Secondary outcomes include VAS change scores at 10, 60, 90 and 120 min, analgesia use, mode of birth and maternal satisfaction.

Statistical analysis: Sample size was calculated to achieve 90% power at an alpha of 0.025 to detect a non-inferiority margin of ≤ 1 cm on the VAS, using a one-sided, two-sample t-test. Baseline demographic and clinical characteristics will be analysed for comparability between groups. Differences in primary (VAS pain score) and secondary outcomes between groups will be analysed by intention to treat and per protocol analysis using Student's t-test and ANOVA.

Conclusion: This study will determine if a single intradermal SWI technique is no less effective than the routinely used four injection technique for lower back pain during labour. The findings will allow midwives to offer women requesting SWI during labour an evidence-based alternative technique more easily administered by staff and accepted by labouring women.

Trial Registration: ACTRN12609000964213.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status Non-UQ
Additional Notes Published under Study protocol. Article # 21.

Document type: Journal Article
Sub-type: Article (original research)
Collections: Non HERDC
School of Medicine Publications
School of Nursing, Midwifery and Social Work Publications
 
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Created: Mon, 28 Mar 2011, 15:08:58 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work