Clinical trial NCT01908738: Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy
Official title: Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy Under Oral Analgesic Drugs; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Biopsy
Abnormal Uterine Bleeding
Keywords: Endometrial biopsy
paracervical block
Lidocaine spray
women
abnormal uterine bleeding
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Participants : This study was conducted prospectively at the outpatient clinic, Department of Obstetrics and Gynecology, Songklanagarind Hospital.

Inclusion criteria : The women who had abnormal uterine bleeding and indication for endometrial biopsy were enrolled.

Exclusion criteria : included 1) contraindications to NSAID or Lidocaine - known sensitivity to these drugs; 2) pregnancy; 3) genital tract infection; 4) coagulation disorder; and 5) unstable vital signs.

Sample size calculation : Sample size was calculated by assuming the different mean pain score of each groups performing the endometrial biopsy to be 1. To evidence this difference with a power of 80% and a 5% level of significance, a need was calculated with 36 women in each group and for total was 108 women.

Z α/2 = Type I error(alpha error) α = 0.05 \>\> 1.96 Z β = Type II error(beta error) β = 0.2 \>\> 0.84

* Variance of mean pain score between procedure and post procedure 15 minutes = 1.5 µ0 = Mean pain score in group 1 µ1 = Mean pain score in group 2 µ0 - µ1 = Different of mean pain score in between each groups = 1 \*\*N = 2(1.5)2(1.96 + 0.84)2/(1)2 = 35.3 N = 36 per group

Study procedures :

1. Explain the steps of the procedure to the patient and counseling regarding rational and risks/benefits. Obtain consent for the procedure. Perform bimanual exam to determine uterine size and position.
2. After signing a written informed consent, the women were randomly allocated to 3 groups. All women will receive Acetaminophen 500 mg and Ibuprofen 400 mg before procedure 30 minutes.

   The first groups receive paracervical block with 1%lidocaine and 0.9%NSS spray(placebo), the second groups receive 10%lidocaine spray and paracervical block with 0.9%NSS(placebo) and the third groups receive placebo both paracervical block and spray. Both women and researcher associate were blinded to group allocation. The 1%lidocaine, 10%lidocaine spray and both placebos were prepared in sequentially numbered sealed opaque envelops according to the table of random numbers by an independent pharmacist.
3. The time that start oral medication and vital signs before starting procedure were recorded.
4. Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. Then administer paracervical block by using local anesthetic drug 5 ml. injects at cervical area 3 and 9 O'clock, depth 0.5-1 cm., 2.5 ml. each sides. After that use anesthetic spray sprays at cervix for 1 times and wait for 3 minutes.
5. Endometrial biopsy was performed by using a 3-mm EndosamplerTM (MedGyn EndosamplerTM, MedGyn Product Inc, IL, USA). If insertion of EndosamplerTM failed, a tenaculum was applied to the anterior cervix to help for stabilization and counter-traction.
6. After get the endometrial tissue sample, remove all equipments, checked and stopped bleeding. And record vital signs after finish the procedure.
7. The form contained a visual analog scale for women to report their responses of pain at immediately after procedure and after that 15 minutes by using Numerical Rating Scale(NRS) were recorded.
8. The women were assessed for adverse side effects or complications of procedure e.g. such as dizziness, nausea, vomiting, pelvic pain or others.
9. Follow up appointment the women for pathological report result at PSU hospital and consider further management.

Expected outcomes :

To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.

Table. 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 A secondary goal of this study was to determine the adverse effects of these methods(such as dizziness, nausea, vomiting, pelvic pain, bleeding).

Data analysis :

Data are presented as median (range) for quantitative variables and frequency for qualitative variables. Comparison between both groups was made by using the Chi-square test, Fisher's exact test and Mann-Whitney U test where appropriate with p\<0.05 considered statistically significant. Statistical analysis was performed with the SPSS 17.0 package program (Statistical Package for Social Science; SPSS Inc., Chicago, IL, USA).

Ethical consideration :

* Inform consent will be obtained before study procedure.
* The study will not detrimental patients or treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* abnormal uterine bleeding women
* indicated for endometrial biopsy

Exclusion Criteria:

1. contraindications to NSAID or Lidocaine - known sensitivity to these drugs
2. pregnancy
3. genital tract infection
4. coagulation disorder
5. unstable vital signs.

Primary outcomes:
measure: Effectiveness of paracervical block VS Lidocaine spray during endometrial biopsy ; A randomized controlled trial
timeFrame: up to 12 months
Secondary outcomes:
measure: adverse effects of paracervical block versus lidocaine spray
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Songkla
country: Thailand
facility: Akarawit Jitchanwichai
state: Hatyai
Study officials:
References: