Sterile Water Injections For Pain Relief İn Labor

Overview

ABSTRACT Introduction: In addition to pain caused by uterine contractions in labour, in 33% of women, continuous and severe back pain is observed. In management of this pain, sterile water injection is considered to be an effective method. Aim of this study is assessment of effectiveness and satisfaction of this method among Turkish women in which analgesic methods are not extensively used in labour and rates of cesarean section exponentially increases. Material and Methods: 168 termed, healthy women who admitted to Istanbul Gaziosmanpaşa-Taksim Training and Research Hospital with labour pain and had severe back pain were randomized into 4×0.1 ml sterile water and 4xdry Injection groups. Injections were applied to Michaelis Rhomboid region in sacral region. Pain scores were assessed at 10th, 30th, 60th, 120th and 180th minutes with Visual Analog Scale (VAS). Additionally, need for epidural analgesia, APGAR score, mode of delivery, time of delivery, maternal satisfaction and breastfeeding scores were assessed.

Full Title of Study: “Intradermal Sterile Water Injections for Labour Pain: A Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2014

Interventions

  • Other: Sterile Water
    • 0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
  • Other: Dry Injections
    • dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.

Arms, Groups and Cohorts

  • Experimental: Sterile Water Injection
    • Participants randomised to the intervention group received 4 intracutaneous injections of 0.1 ml sterile water into the skin surrounding the Michaelis rhomboid over the sacral area.
  • Placebo Comparator: Dry Injection
    • Participants in the control group received 4 dry injections in the same region using an insulin needle .

Clinical Trial Outcome Measures

Primary Measures

  • Pain scores-30
    • Time Frame: at 30 mins after interventions
    • In pain scoring Visual Analog Scale was used

Secondary Measures

  • Pain scores-10
    • Time Frame: at 10 mins after interventions
    • In pain scoring Visual Analog Scale was used
  • Pain scores-60
    • Time Frame: at 60 mins after interventions
    • In pain scoring Visual Analog Scale was used
  • Pain scores-90
    • Time Frame: at 90 mins after interventions
    • In pain scoring Visual Analog Scale was used
  • Pain scores-120
    • Time Frame: at 120 mins after interventions
    • In pain scoring Visual Analog Scale was used
  • Pain scores-180
    • Time Frame: at 180 mins after interventions
    • In pain scoring Visual Analog Scale was used
  • APGAR score of neonate
    • Time Frame: at 5 mins after birth
  • Maternal satisfaction
    • Time Frame: at 1 hour after birth
    • Likelihood to use again with subsequent labour, Women satisfaction with analgesic effect, Likelihood to recommend to SWI to others
  • Rates of breastfeeding-1
    • Time Frame: at 1 hour after birth
    • In breastfeed scoring The Infant Breastfeeding Assessment Tool was used
  • Rates of breastfeeding-24
    • Time Frame: at 24.hours after birth
    • In breastfeed scoring The Infant Breastfeeding Assessment Tool was used

Participating in This Clinical Trial

Inclusion Criteria

  • Aged between 18-35 – 37-42 weeks of gestation – Expecting vaginal delivery – Cephalic presentation – Single, healthy fetus – Spontaneous onset of labor – Active phase of first stage of labor (3-7 cm cervical dilatation) – Severe low back pain (VAS>7cm) – Required pain relief Exclusion Criteria:

  • Gestation <37 weeks – Multiple pregnancy – Malpresentation – Second stage labour – Pharmacological analgesia prior to SWI – Back pain assessed by VAS <7 – Women whose labour would be considered high risk

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Beykent
  • Provider of Information About this Clinical Study
    • Principal Investigator: refika genç koyucu, assist.prof. – University of Beykent

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