Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy

NCT01908738 | Completed DMC

• 1 other identifier: 56-244-12-4-2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Conditions

Endometrial Biopsy; Abnormal Uterine Bleeding

Keywords

Endometrial biopsy; paracervical block; Lidocaine spray; women; abnormal uterine bleeding

Outcome Measures

Primary Outcomes (1)

• Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial

  measurement outcome by record Pain score(NRS)\[Numberical rating scale 0-10\] immediately after procedure and 15 minutes after procedure in all groups Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Group 3 Control group(Placebo) Pain score immediately and Pain score 15 minutes were compared between group by using statistic analysis to indentify the significant of decreasing Pain score for pain relief during endometrial biopsy. And after that the result will used to determine effectiveness of each groups\[ paracervical block, lidocaine spray and only oral analgesic drugs.

  up to 12 months

Secondary Outcomes (1)

• adverse effects of paracervical block versus lidocaine spray

  up to 12 months

Study Arms (3)

paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)

EXPERIMENTAL

first groups receive paracervical block with 1%lidocaine and 0.9%NSS spray(placebo)

Drug: paracervical block with 1%lidocaine

10%lidocaine spray and paracervical block with 0.9%NSS

EXPERIMENTAL

the second groups receive 10%lidocaine spray and paracervical block with 0.9%NSS(placebo)

Drug: 10%lidocaine spray

receive placebo both paracervical block and spray

PLACEBO COMPARATOR

the third groups receive placebo both paracervical block and spray

Drug: paracervical block with 1%lidocaine; Drug: 10%lidocaine spray

Interventions

paracervical block with 1%lidocaine DRUG

To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy. Pain score(NRS) immediately after procedure and 15 minutes Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Control group(Placebo) Pain score immediately Pain score 15 minutes

paracervical block with 1%lidocaine and 0.9%NSS spray(placebo); receive placebo both paracervical block and spray

10%lidocaine spray DRUG

10%lidocaine spray and paracervical block with 0.9%NSS; receive placebo both paracervical block and spray

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• abnormal uterine bleeding women
• indicated for endometrial biopsy

You may not qualify if:

• contraindications to NSAID or Lidocaine - known sensitivity to these drugs
• pregnancy
• genital tract infection
• coagulation disorder
• unstable vital signs.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Akarawit Jitchanwichai

Songkhla, Hatyai, 90110, Thailand

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Anesthesia, Obstetrical

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty of medicine obstertic and gynecology

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 23, 2017

Record last verified: 2014-03

Locations

TH (1)