Journal Article

Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial

Barnett, Belinda, Mårtensson, Lena B., Gao, Yu, Callaway, Leonie, Kildea, Sue, Lee, Nigel

2022

Overview

Background Up to 80% of women use some form of pharmacological analgesia during labour and birth. The side effects of pharmacological agents are often incompatible with the concurrent use of non-pharmacological pain relieving strategies, such as water immersion, ambulation and upright positioning, or may have negative effects on both the mother and fetus. Sterile water injections given into the skin of the lumbar region have been demonstrated to reduce back pain during labour. However, the injections given for back pain have no effect on abdominal contraction pain. The analgesic efficacy of sterile water injections for abdominal pain during childbirth is unknown. The injections cause an immediate, brief but significant pain that deters some women from using the procedure. This study aims to investigate the use of water injections given intradermally into the abdomen to relieve labour contraction pain. A vapocoolant spray will be applied to the skin immediately prior to the injections to reduce the injection pain. Methods In this pragmatic, placebo controlled trial 154 low-risk women in labour at term with a labour pain score ≥ 60 on a 100 millimitre visual analogue scale (VAS) will be randomly allocated to receive either six injections of sterile water or a sodium chloride 0.9% solution as a placebo (0.1–.0.3 ml per injection). Three injections are given along the midline from the fundus to the supra-pubis and three laterally across the supra-pubis. The primary outcome will be the difference in VAS score 30 min post injection between groups. Secondary outcomes include VAS score of the injection pain on administration, VAS score of labour pain at 60 and 90 min, maternal and neonatal birth outcomes. Discussion Access to effective pain relief during labour is fundamental to respectful and safe maternity care. Pharmacological analgesics should support rather than limit other non-pharmacological strategies. Sterile water injections have the potential to provide an alternative form of labour pain relief that is easy to administer in any labour and birth setting, and compatible with other non-pharmacological choices. Trial registration ANZCTR (ACTRN12621001036808) Date submitted: 22/06/2021. Date registered: 05/08/2021. https://www.anzctr.org.au/

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Abdomen / adverse event / Analgesia / Analgesia, Obstetrical - adverse effects / Analgesia, Obstetrical - methods / Analgesics / Anesthesia / Back pain / Biomedicine / Birthing centers / Care and treatment / Childbirth & labor / Consent / Epidural / Familjecentrerad hälsa (FamCeH) / Family-Centred Health / Female / Health aspects / Health Sciences / human / Humans / Infant / Infant, Newborn / labor / labor pain / Labor Pain - diagnosis / Labor Pain - drug therapy / Labor, Obstetric / Labour pain / maternal health service / Maternal Health Services / Medicine / Medicine & Public Health / Midwifery / Narcotics / newborn / Nitrous oxide / Nursing schools / Obstetric / obstetric analgesia / Obstetrical / Pain / Patient outcomes / Pragmatic Clinical Trials as Topic / Pregnancy / Pregnancy, Complications of / procedures / Randomised controlled trial / randomized controlled trial (topic) / Randomized Controlled Trials as Topic / Risk factors / Statistics for Life Sciences / Sterile water injections / Study Protocol / Water / Womens health