Effect of local anaesthesia at vaginal hysterectomy on post-op pain

• Research type

  Research Study

• Full title

  Double blind randomised multicentre study to assess the effect of local anaesthesia during vaginal hysterectomy

• IRAS ID

  126457

• Contact name

  Linda Cardozo

• Contact email

  linda@lindacardozo.co.uk

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2013-004124-11

• Research summary

  The use of local anaesthetic and adrenaline (LA) infiltration during vaginal hysterectomy offers theoretical benefits including reduced post-operative pain, shorter operating times due to hydrodissection and decreased intra-operative bleeding, less post-operative haematoma formation and infective morbidity. However, there remains substantial variation in practice, and the limited existing evidence is conflicting.

  This two-arm parallel group randomised study aims to compare effect of LA infiltration vs. saline infiltration at vaginal hysterectomy on post-operative pain, operative blood loss, operating time and post-operative recovery and morbidity.

  Co-primary outcome measures
  • Patient's requests for post-operative analgesia use
  • Short-form McGill pain questionnaire
  Secondary outcome measures
  • Intra-operative blood loss, operating time, duration of inpatient stay, incidence of post-operative morbidity

  The target sample size is 206 participants, with broad pragmatic inclusion criteria, aiming to enable units around the world to recruit rapidly.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  14/EM/1074

• Date of REC Opinion

  11 Aug 2014

• REC opinion

  Further Information Favourable Opinion