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; Kildea, Sue
January 2011
BMC Pregnancy & Childbirth;2011, Vol. 11 Issue 1, p21
Academic Journal
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


Related Articles

  • Labour Analgesia When Epidural Is Not a Choice: Tramadol versus Pentazocine. Shetty, Jyothi; Vishalakshi, Ashwini; Pandey, Deeksha // ISRN Obstetrics & Gynecology;2014, p1 

    Background. Parenteral opioids, thus, are still popular for pain relief in labor in many countries throughout the world. Aim. To evaluate and compare the efficacy of intramuscular tramadol and pentazocine in the first stage of labor. Method. Sixty-five patients were divided into pentazocine...

  • Lower back pain in labour. Rubio-Batanas, Maria Del Carmen // British Journal of Midwifery;Mar2014, Vol. 22 Issue 3, p226 

    The article discusses the use of sterile water injection (SWI) to reduce lower back pain in labour. It provides a background of SWI including the concept behind its development and the technique for its administration. It also cites the refusal of the British National Institute for Health and...

  • Clinical outcome following DIAM implantation for symptomatic lumbar internal disk disruption: a 3-year retrospective analysis. Kang Lu; Po-Chou Liliang; Hao-Kuang Wang; Jui-Sheng Chen; Te-Yuan Chen; Ruyi Huang; Han-Jung Chen // Journal of Pain Research;Oct2016, Vol. 9, p917 

    Background/objective: Internal disk disruption (IDD), an early event of lumbar disk degeneration, is the most common cause of low back pain. Since increased intradiskal pressure (IDP) is associated with symptoms and progression of disk degeneration, unloading a painful disk with an interspinous...

  • My lower back is stiff and achy in the morning. What can I do? Rossetti, Pamela // Prevention;Aug2013, Vol. 65 Issue 8, p70 

    The article provides an answer to question on how to reduce the pain of lower-back pain and stiffness.

  • Why Would Two Patients with No Disease Be Offered Unnecessary Transforaminal Lumbar Interbody Fusions (TLIF)? Epstein, Nancy E. // Surgical Neurology International;6/25/2019, Vol. 10, p1 

    Highlights from the article: (TLIF) being offered to patients with no disease (i.e. pain alone with no neurological deficit, or Epstein: Why Would Two Patients With No Disease Be Offered Unnecessary Transforaminal Lumbar Interbody Fusions (TLIF)?.

  • Labor Analgesia. Schrock, Steven D.; Harraway-Smith, Carolyn // American Family Physician;3/1/2012, Vol. 85 Issue 5, p447 

    Regional analgesia has become the most common method of pain relief used during labor in the United States. Epidural and spinal analgesia are two types of regional analgesia. With epidural analgesia, an indwelling catheter is directed into the epidural space, and the patient receives a...

  • Continuous infusion of Remifentanil plus Ketamine compared with continuous Remifentanil for pain relief in labor. Tazeh-kand, Nasrin Faridi; Moini, Ashraf; Eslami, Bita; Khajehdehi, Anooshe // Medical Journal of the Islamic Republic of Iran;Dec2011, Vol. 25 Issue 4, p171 

    Background: Pain relief during labor is an important determinant of a women's birth experience. There are numerous pain relief techniques which can be used either with or without pain medication. The aim of our study was to compare the effect of remifentanil alone and its effect in pain relief...

  • EPIDURALNA ANALGEZIJA U POROĐAJU: SPECIFIÄŒNOSTI, DILEME I KONTROVERZE. KUTLEŠIĆ, Marija; KUTLEŠIĆ, Ranko // Medicinski Pregled / Medical Review;sep/okt2012, Vol. 65 Issue 9/10, p441 

    Introduction. Epidural analgesia has become the most popular method for labor pain relief. Analgesia in Labor: Yes or No? Labor pain is a complex phenomenon with sensory, cognitive, motivational, emotional, social, and cultural variables. Pain and anxiety lead to adrenergic hyperactivity,...

  • AMBULATORY EPIDURAL ANALGESIA FOR PAINLESS LABOUR: COMPARISON BETWEEN BUPIVACAINE PLUS FENTANYL AND BUPIVACAINE PLUS TRAMADOL. Wahid, Sami; Noreen, Uzma; Haq, Imran ul; Raza, Ahmed; Hanif, Faisal; Waqas, Ahmed // Gomal Journal of Medical Sciences;Jul-Dec2012, Vol. 10 Issue 2, p54 

    Background: In modern obstetrics alleviation of labour pains by simple, safe and effective means presents a unique problem. Epidural analgesia has emerged as a popular and relatively safe option. This study was conducted to compare the efficacy of bupivacaine plus tramadol and bupivacaine plus...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics