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Active, not recruitingNCT06344637Updated Apr 3, 2024

Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration

An interventional study of 10 % lidocaine spray without adrenaline and Placebo in Pain, Procedural, Lidocaine and Obstetric Surgical Procedures, sponsored by UdonThani Hospital. Active, not recruiting at 1 site in Thailand. Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by UdonThani Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
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Study summary

This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration

Read the detailed description

This is a double blinded, placebo controlled study which compose of two arms. The treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. The control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. The outcome is to compare the visual analog pain score during and after procedure.

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Conditions studied

  • Pain, Procedural
  • Lidocaine
  • Obstetric Surgical Procedures

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Keywords

  • manual vacuum aspiration
  • pain score
  • Lidocaine spray
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In context

Pain, Procedural

237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's enrollment of 216 is above the median of 83 across 223 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

This is the only study on the registry with UdonThani Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia

Exclusion criteria

Exclusion Criteria:

  • patient with allergic to lidocaine or history of allergic to lidocaine
  • patient with reproductive and urinary infection
  • patient with abnormal vital sign
  • patient with abnormal kidney and liver function test
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
216 participants (actual)

Study arms

  • Experimental
    10% lidocaine spray without adrenaline

    4 puffs of 10% lidocaine spray without adrenaline apply on cervical os before manual vacuum aspiration

    Drug: 10 % lidocaine spray without adrenaline

  • Placebo comparator
    Placebo

    4 puffs of normal saline apply on cervical os before manual vacuum aspiration

    Other: Placebo

Interventions

  • Drug10 % lidocaine spray without adrenaline

    Pateint with indication for manual vacuum aspiration aged between 20-60 years will received a standard injection of pethidine along with 1% lidocaine spray without adrenaline on cervical os to compare pain scores with placebo. Along with measuring side effects immediately and 30 minutes after receiving 1% lidocaine without adrenaline.

    Also known as: 10% Xylocaine spray

  • OtherPlacebo

    4 puffs of normal saline apply on cervical os before manual vacuum aspiration

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What researchers measure

Primary outcomes

  1. pain score during manual vauum aspiration

    The pain score using visual analog scale is used to assess the pain score during the manual vacuum aspiration during procedure (score 0-10), the 0 score is no pain and the 10 score is the maximum pain

    Time frame: during surgery

  2. pain score after manual vauum aspiration

    The pain score using visual analog scale is used to assess the pain score after the procedure (score 0-10) the 0 score is no pain and the 10 score is the maximum pain

    Time frame: at 30 minutes postoperative

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Study locations

1 site
  • UdonThani Hospital
    Udon Thani, UdonThani 41000, Thailand
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 30, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06344637
Lead sponsor
UdonThani Hospital
Responsible party
Metha Songthamwat (Principal investigator, UdonThani Hospital) — Principal investigator
First posted
Apr 3, 2024
Start date
Dec 14, 2023
Primary completion
May 30, 2024 (estimated)
Completion
Jul 30, 2024 (estimated)
Last update
Apr 3, 2024

Study contacts

PATTARIKAN MANAYING
principal investigator · UdonThani Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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