Perineal Local Infiltration Study

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The prevalence of birth canal lacerations is more than 70% of all deliveries in Canada. The repair of such lacerations is usually done using a pre-existing epidural analgesia. Once the analgesic effect of the epidural analgesia fades, the laceration may cause intolerable pain, and result in emotional stress, difficulties in ambulation and breastfeeding, and more.

The research team hypothesis is that adding a locally injected analgesic, which will take effect once the epidural analgesia fades, may alleviate perineal pain, prevent such difficulties, and improve women's overall well-being and satisfaction.

The proposed trial is a two-arm, single-masked, randomized trial. Women with a working epidural analgesia, and a laceration will be invited to participate. Women in the local anesthesia (LA) arm will get a LA injected to the laceration and women in the sham arm will get no injection. The differences in perineal pain between the groups will be evaluated at 6 hours after last epidural dose.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Bupivacaine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Maternal age > 18 years of age

• Gestational age≥34 weeks of gestation

• Vaginal delivery

• Perineal laceration (2PT/Epi)

• Effective epidural anesthesia

• No known hypersensitivity to bupivacaine or amino-amide anesthetics

Exclusion Criteria:

• Medical history of a chronic pain syndrome

• Intrapartum morphine use