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A Randomised Double Blind Placebo Controlled Trial-Local Anaesthesia and Pain Perception during Amniocentesis

Local Anaesthesia and Pain Perception during Amniocentesis-A Randomised Double Blind Placebo Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028469
Enrollment
138
Registered
2020-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O359- Maternal care for (suspected) fetal abnormality and damage, unspecified

Interventions

Intervention1: Lignocaine Spray: Lignocaine spray will be applied on maternal abdominal wall before starting of Amniocentesis and pain score will be assesed Control Intervention1: Normal saline spray:

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy and gestational age 15-24 weeks based on reliable last menstrual period and/or sonographic biometry in 1st trimester of pregnancy (11 to 13+6 weeks) having following indications- h/o chromosomal abnormality in baby high risk/intermediate risk cases according to aneuploidy results Nuchal translucency >3.5 mm Previous syndromic baby ,parents having balanced translocation,usg suggestive of any structural abnormality

Exclusion criteria

Exclusion criteria: patient having history of lignocaine allrgy inability to rate pain score by visual analogue scale patient refusal abnormal sensory function based on history

Design outcomes

Primary

MeasureTime frame
To compare the effect of lignocaine spray with placebo on pain perception due to amniocentesis at the time of procedure by VAS and VRSTimepoint: 0 minutes(immediately after the procedure)

Secondary

MeasureTime frame
To document the difference between pain scores after 30 minutes of procedure in the 2 groups To document various indications of amniocentesis and complications associated with it like abortion ,infection,leaking or bleeding pv To document the incidence of aneuploidies in high risk and intermediate risk group To evaluate the overall perception of the procedure To find out the agreement between VAS and VRSTimepoint: Pain perception after 30 minutes of procedure Complications-0 minutes till 2 weeks after procedure Incidence of aneuploidies-3 weeks

Countries

India

Contacts

Public ContactDr Tanya Sharma

AIIMS Jodhpur

meenakshigothwal@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026