Effectiveness of Lidocaine Spray Combined with Oral Paracetamol versus Oral Paracetamol Alone for Pain Reduction in Diagnostic Amniocentesis: A randomized controlled trial
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Abstract
Objectives: To determine whether lidocaine spray at the amniocentesis puncture site, combined with oral paracetamol, reduced procedural pain compared with paracetamol alone.
Materials and Methods: We conducted a randomized, double-blind, placebo-controlled trial at a tertiary care hospital (August 2024–June 2025). A total of 192 pregnant women undergoing diagnostic amniocentesis were randomized equally into two groups. The intervention group (n = 96) received 10% lidocaine spray, and the control group (n = 96) received placebo spray identical in appearance. All participants received oral paracetamol. Pain intensity at needle insertion (visual analog scale (VAS), 0–10) was the primary outcome. Secondary outcomes included VAS at other time points (during aspirate amniotic fluid and needle withdrawal, 15 and 30 minutes), maternal anxiety (State-Trait Anxiety Inventory), and satisfaction.
Results: Baseline characteristics were comparable between groups. Pain scores were significantly lower in the lidocaine group at needle insertion (median 4, interquartile range (IQR) 2–5 vs 5, IQR 3–6, p = 0.016), needle withdrawal (median 2, IQR 0–3 vs 3, IQR 1–5, p = 0.003), at 15 minutes (median 0, IQR 0–2 vs 0.5, IQR 0–3, p = 0.031), and at 30 minutes (median 0, IQR 0–1 vs 0, IQR 0–1.5, p = 0.091). Anxiety scores were similar between groups, whereas satisfaction scores were higher in the lidocaine group (mean ± standard deviation = 4.40 ± 0.67 vs 4.06 ± 0.77).
Conclusion: Lidocaine spray combined with oral paracetamol significantly reduced pain during and immediately after the procedure, and increased maternal satisfaction. This simple, safe, and low-cost approach may enhance maternal comfort during diagnostic amniocentesis.
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