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Intrauterine Lidocaine versus Placebo in Conjunction with Paracervical Block for Pain Relief During Fractional Curettage: A Randomized Controlled Trial

The effects of intrauterine lidocaine in conjunctive with paracervical block compared to placebo on pain during the procedure, adverse effects and additional drug requirement in women with abnormal uterine bleeding who undergoing fractional and curettage

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000449932
Enrollment
230
Registered
2011-05-03
Start date
2010-11-15
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Fractional curettage is one of a minor gynecologic procedure, routinely performed in order to diagnosis and treatment in women with abnormal uterine bleeding. Because patient might suffer from pain during the procedure, therefore local anesthesia or analgesics are used to relief pain. Paracervical block has been initiated since 1925. However, its effectiveness in pain reduction during fractional curettage is inconclusive. In some studies, they found that many patients still getting moderate pain and additional painkillers were needed in both during and after the procedure. To our knowledge, the mechanism of action of paracervical block is blocking nerve impulse at uterovaginal plexus (Frankenhauser’s plexus) which provide nerve conduction to cervix and lower uterine segment. Therefore, paracervical block is inadequate for pain relief in case of performing uterine intervention such as fractional curettage. Theoretically, intrauterine lidocaine can block nerve conduction at nerve ending providing for endometriuim, corpus and fundus. In practical, intrauterine lidocaine for fractional curettage has not yet widely performed due to its complexity to perform and needed experienced hands. However, There are many studies conducted randomized controlled trial comparing between the Intrauterine lidocaine and paracervical block or other anesthesia or analgesia for pain relief during many gynecologic procedure such as hysteroscopy, endometrial sampling, dilatation curettage, suctional curettage, fractional curettage, removal of lost IUD, etc. The results revealed that intrauterine lidocaine was superior to placebo or other forms of anesthesia in pain reduction with statistically significance. No prior systematic review compared between paracervical block alone and paracervical block in conjunctive with intrauterine lidocaine for pain relief during fractional curettage. Hence, the author plan to conduct randomized controlled trial to assess the effectiveness of intrauterine lidocaine for pain reduction in women with abnormal uterine bleeding who undergoing fraction and curettage. Adverse effects of both interventions and additional anesthetic or analgesia requirement are also evaluated.

Interventions

Arm1: Intrauterine lidocaine in conjunction with paracervical block (2% Lidocaine 5 ml intrauterine instillation and paracervical block 5 ml each side), single dose

Sponsors

Khon Kaen Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Women with abnormal uterine bleeding who undergoing fractional and curettage

Exclusion criteria

Pregnancy Hx of lidocaine hypersensitivity Hx of bleeding disorders Hx of impaired LFT Taking anti-coagulants Genital organ infection Profuse uterine bleeding or vital signs unstable

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026