Pain, Postoperative Clinical Trial
Official title:
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
| NCT number | NCT03944291 |
| Other study ID # | AS1871 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 1, 2019 |
| Est. completion date | January 20, 2020 |
| Verified date | January 2020 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial
| Status | Completed |
| Enrollment | 102 |
| Est. completion date | January 20, 2020 |
| Est. primary completion date | January 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus Exclusion Criteria: - Women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. Also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of the study |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Ain Shams University Maternity Hospital | Cairo |
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analogue Scale for pain scoring | visual analogue scale (VAS) from 0 to 100 with 0 corresponding to no pain at all and 100 as the worst pain the woman can describe | 48 hours |
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