The KAPT-PARA Block trial

• Research type

  Research Study

• Full title

  Comparative Analysis of Pain Relief between KAPT Block and Paracervical Block for Outpatient Hysteroscopy Procedures

• IRAS ID

  339976

• Contact name

  Raphael Laiyemo

• Contact email

  raphael.laiyemo@nhs.net

• Sponsor organisation

  Sherwood Forest Hospitals NHS Foundation Trust

• ISRCTN Number

  ISRCTN15619382

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  A total of 52 patients will be recruited to allow for withdrawals. 48 patients in total required for the analysis.
  
  1. Randomised control trial to evaluate and compare the pain scores of women undergoing outpatient hysteroscopy when administered either the KAPT Block or the Paracervical Block, with an emphasis on understanding the relative efficacy of these two anaesthetic techniques.

  2. To determine which method, KAPT Block or Paracervical Block, offers superior pain relief at critical stages of the outpatient hysteroscopy procedure: during cervical dilatation, throughout the procedure, and 10 minutes post-procedure. This will involve a detailed analysis of pain scores at these specific time intervals.

  - Participants will be randomly allocated to either the KAPT Block group or the Paracervical Block group.
  Inclusion:
  - Women attending outpatient hysteroscopy procedures at Kings Mill Hospital.
  - Age 18 years and above.
  - Willing to participate and able to provide informed consent.

  Exclusion:
  - Women with genital infections
  - Women with known contraindications to local anaesthetics.
  - Women with a history of allergic reactions to the anaesthetics used.
  Pain levels will be assessed using the Visual Analogue Scale (VAS) at three key stages:
  - During cervical dilatation.
  - During the procedure.
  - 10 minutes post-procedure.
  For each time point, pain will be rated on a 0-10 scale, allowing a maximum cumulative VAS score of 30 for each patient.
  An average score will then be calculated.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  24/EM/0036

• Date of REC Opinion

  22 Apr 2024

• REC opinion

  Further Information Favourable Opinion