Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Woman's Health University Hospital, Egypt

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Low Back Pain

Treatments: Other: saline injection; Other: Subcutaneous sterile water injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02813330

Women Health Hospital

Details and patient eligibility

About

To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Full description

Study sample:

The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection)

Setting:

Labor ward in Women's health center at Assiut university hospital

Study design:

Experimental Randomized control study

Sample size:

The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria

• In labour (spontaneous or induced
• During first stageof labour
• Primary and multiparous women
• A term singleton pregnancy (between 37 + 0 and 41 weeks)
• Have a fetus in a cephalic presentation
• Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003)
• Provide informed consent.

Exclusion criteria

• Multiple pregnancy
• Malpresentation (breech, transverse, shoulder)
• Previous CS
• Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia.

Study Tools:

1. Personal data questionnaire
2. Visual Analogue Scale and Face analogue scale
3. Satisfaction scale

Enrollment: 336 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In labour (spontaneous or induced record
• During first stage of labour
• Primary and multiparous women
• A term singleton pregnancy (between 37 + 0 and 41 weeks)
• Have a fetus in a cephalic presentation
• Experience back pain assessed by visual analogue scale VAS and Face pain analogue
• Provide informed consent.

Exclusion criteria

• Women with chronic disease
• Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc)
• Complicated labor process ( obstructed, preterm labor, twins)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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336 participants in 2 patient groups

Sterile Water injection

Experimental group

Description:

Subcutenous injection at low back portion during labor pain

Treatment:

Other: Subcutaneous sterile water injection

Other: saline injection

saline injection

Experimental group

Description:

Subcutenous injection at low back portion during labor pain

Treatment:

Other: Subcutaneous sterile water injection

Other: saline injection