Sterile Water Injections For Pain Relief İn Labor

University of Beykent

Status: Completed

Conditions: Back Pain; Labour Pain

Treatments: Other: Sterile Water; Other: Dry Injections

Study type: Interventional

Funder types: Other

Identifiers

NCT02697994

SWI1315

Details and patient eligibility

About

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 4x0.1 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.

Enrollment: 168 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 2 patient groups, including a placebo group

Sterile Water Injection

Experimental group

Description:

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.

Treatment:

Other: Sterile Water

Dry Injection

Placebo Comparator group

Description:

Participants in the control group received 4 dry injections in the same region using an insulin needle .

Treatment:

Other: Dry Injections