MedTrace Logo

Perineal Local Infiltration Study

NCT03672500 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Second Degree Perineal Tear During Delivery - Delivered
  • Episiotomy; Complications
  • Anesthesia, Local

Interventions

DRUG

Bupivacaine 0.5%+Epinephrine 50mc

Local infiltration of the perineum with Bupivacaine 0.5%+Epinephrine 50mc

OTHER

Sham injection

Sham injection of the perineum

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Amir Aviram, MD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2022-05-09
Completion
2022-05-09

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03672500 on ClinicalTrials.gov