None listed
Conditions
Brief 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.
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 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
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
Sponsors
Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Singleton pregnancy Vaginal delivery Second degree vaginal-perineal tear
Exclusion criteria
Epidural for delivery Current illicit drug use Coagulation disorder for use of anticoagulants Major labial tears
Outcome results
None listed