Not Yet RecruitingPhase 4ACTRN12619000056190

Perineal Repair Trial. Comparing different types of local anaesthetic for perineal repair following childbirth

Local anaesthetic for perineal repair following vaginal delivery: A randomised controlled trial


Sponsor

Royal Women's Hospital

Enrollment

210 participants

Start Date

Feb 4, 2019

Study Type

Interventional

Conditions

Summary

A single blinded, randomised controlled trial in women who sustain second degree vaginal tears, to assess whether the use of either Ropivacaine or Lignocaine with Adrenaline infiltration prior to vaginal-perineal repair results in either reduced blood loss or reduced pain compared to standard treatment with lignocaine.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • Singleton pregnancy
  • Vaginal delivery
  • Second degree vaginal-perineal tear

Exclusion Criteria4

  • Epidural for delivery
  • Current illicit drug use
  • Coagulation disorder for use of anticoagulants
  • Major labial tears

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Interventions

Randomisation of local anaesthetic used for local infiltration prior to repair of second degree vaginal-perineal tears. Local anaesthetic (arm 1, arm 2 or arm 3) will be administered by local subcuta

Randomisation of local anaesthetic used for local infiltration prior to repair of second degree vaginal-perineal tears. Local anaesthetic (arm 1, arm 2 or arm 3) will be administered by local subcutaneous infiltration to the vagina and perineum on a once-only basis by the health professional performing the repair (midwife, or obstetric resident / registrar), immediately prior to performing the repair. Vaginal-perineal repair will then be conducted as per institutional protocols. 3 Arms: Arm 1 - Lignocaine 1% - 20mls Arm 2 - Ropivacaine 0.75% - 20mls Arm 3 - Lignocaine 1% with adrenaline 1 in 200,000 - 20mls


Locations(1)

VIC, Australia

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ACTRN12619000056190