Effectiveness of lidocaine spray with oral paracetamol compare with oral paracetamol for pain reduction in diagnostic amniocentesis at Udonthani hospital: a randomized controlled trial

Effectiveness of lidocaine spray with oral paracetamol compare with oral paracetamol for pain reduction in diagnostic amniocentesis: a randomized controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241028001

Enrollment

246

Registered

2024-10-28

Start date

2024-08-13

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pregnancy women who diagnosis amniocentesis have pain during procedure. Previous study shows lidocaine spray can reduce pain in diagnostic amniocentesis compare with placebo and oral paracetamol can reduce pain in diagnostic amniocentesis compare with placebo. I will study Effectiveness of lidocaine spray with oral paracetamol compare with oral paracetamol for pain reduction in diagnostic amniocentesis in second trimester pregnancy. To be used the best pain relief at Udonthani hospital. diagno

Interventions

Pregnancy women who inclusion criteria, used paracetamol 500 1-hour before procedure and Spray 10% lidocaine 8 puffs on abdomen where needle insertion 5 minutes before procedure, then procedure and re

Experimental Drug,Placebo Comparator Drug

lidocaine spray with oral paracetamol,oral paracetamol only

Eligibility

Sex/Gender

Female

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: Pregnant women aged 20 years and over with a pregnancy of 16-22 weeks who have an indication for amniocentesis and receive amniocentesis services at Udonthani Hospital During the study period.

Exclusion criteria

Exclusion criteria: 1. Allergy to lidocaine anesthetic or a history of allergic reactions to anesthetics, 2. Allergy to paracetamol or a history of allergic reactions to paracetamol, 3. An inflammatory and infected wound on the abdominal skin in the area of the procedure, 4. Pregnancy with more than one fetus, 5. HIV infection, 6. Threatened abortions with persistent pain or bleeding, 7. Abnormal vaginal bleeding of unknown cause, 8. Thrombocytopenia or abnormal coagulopathy.

Design outcomes

Primary

Measure	Time frame
pain score procedure (needle inserted) visual analog scale	—

Secondary

Measure	Time frame
pain score 15 and 30 minutes after procedure visual analog scale,satisfaction score end procedure satisfaction score,Anxiety before and after procedure State trail anxiety inventory	—

Countries

Thailand

Contacts

Public ContactNattakan Jiratitipat

Udonthani hospital

jiratitipat_lek@hotmail.com042215100

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026