Topical Analgesia for Pain Relief in Hysterosalpingography
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The study will involve giving topical analgesia or placebo and then assessing pain and
      satisfaction during and after the procedure in order to see wed to the placebo.hether the
      topical analgesia has helped in decreasing pain associated with the procedure and also
      whether it has increasedd satisfaction with the procedure compar
    

Detailed description: 
      STUDY DESIGN:

      The study will be a double blind randomized controlled trial. Group A:The study group will be
      given topical Xylocaine (2% Lidocaine) before the procedure.

      Group B:The control group will be given topical K-Y jelly (water based lubricant) before the
      procedure.

      The participants and the radiologist will be blinded at the point of drug administration.

      SAMPLE SIZE DETERMINATION:

      The formula below was used to calculate the sample size n= (Zα + Zβ)2S2 d2

      Assuming a difference in mean pain score among groups of 1.5 and using a standard deviation
      of of 3.15.

      Zα = standard normal deviate. Zβ = power = 95% = 1.64. S = standard deviation = 3.1. D = mean
      difference in pain score = 1.5 n = (1.96 + 1.64)2 x 3.12 1.52

      n = 55 Sample size per group will be rounded up to 60

      SAMPLING APPROACH:

      A probability sampling method will be used. Simple random sampling using a computer generated
      table of random numbers will be used. The WINPEPI version 11.65 software will generate the
      table of random numbers. The numbers 001-140 will be randomly allocated to two groups A and
      B. Group A will be the study group and group B will be the control group (see appendix). Each
      number from the table of random numbers will be copied on separate paper and then sealed in a
      brown envelope. The envelopes will then be kept inside a box after shuffling.

      Each patient will be allocated to the group that the number she picks corresponds to on the
      computer printout. The numbers were made up to 140 to make up for patients that may
      eventually drop out from the study.

      .

      SAMPLING RECRUITEMENT:

      Women that fulfil the inclusion criteria will be recruited from radiology department as they
      present for Hysterosalpingogram. After obtaining a written consent, participants will be
      requested to pick one of the brown envelopes which will contain the randomization group.

      BLINDING The drugs to be used (K-Y Jelly and Xylocaine gel) are identical.

      DATA COLLECTION METHOD:

      An informed written consent will be obtained from participants. Psychological support will be
      given to the participant by a nurse after the procedure has been explained to the
      participant. A questionnaire will then be filled. The participant will then be requested to
      pick an envelope that represents the study number. A detailed explanation about the VAS and
      its application was given personally to each woman before the procedure. An interviewer
      administered questionnaire will be used to obtain information on socio-demographic
      characteristics, reproductive profile, previous history of the procedure and experience with
      analgesia.

      The analgesic or placebo will be applied to the cervix (15ml) using a vaginal applicator 10
      minutes before the procedure.

      The procedure will then be done using standard clinical protocol. The pain rating scale will
      be used to evaluate pain during from zero (no pain) to ten (worst possible pain) will be
      explained to the client. The visual scale comparison to happy, glum, sad and horrified faces
      will also be explained to the patient.

      Pain assessment will be done during the procedure at the following steps:

        1. After application of speculum.

        2. After cervical manipulation (application of tenaculum and catheter).

        3. After filling the uterus with contrast medium.

        4. After withdrawal of speculum and catheter.

        5. Thirty minutes after completing the procedure.

      The Likert scale will be used to assess patient satisfaction following pain management.

      .
    

Intervention name(s): Lidocaine Gel; KY jelly
Intervention type(s): Drug; Drug
Intervention description(s): topical lidocaine gel; topical KY jelly
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised controlled trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: infertility; hysterosalpingography; pain