NCT03944291

Brief Summary

Unilateral vs. Bilateral Pudendal Nerve Block for Post-Episiotomy Pain Relief: A Randomized Clinical Trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

May 8, 2019

Last Update Submit

January 26, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Unilateral PNB

ACTIVE COMPARATOR

Unilateral Pudendal Nerve Block

Procedure: Pudendal Nerve Block

Bilateral PNB

ACTIVE COMPARATOR

Bilateral Pudendal Nerve Block

Procedure: Pudendal Nerve Block

Interventions

Pudendal Nerve BlockPROCEDURE

Pudendal Nerve Block

Also known as: Bupivacaine
Bilateral PNBUnilateral PNB

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Bupivacaine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 9, 2019

Study Start

May 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 20, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

EG(1)