Effectiveness of Paracervical Block Versus Lidocaine Spray During Endometrial Biopsy
Condition: Endometrial Biopsy; Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional

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.
    

Intervention name(s): paracervical block with 1%lidocaine; 10%lidocaine spray
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Endometrial biopsy; paracervical block; Lidocaine spray; women; abnormal uterine bleeding