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Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations

NCT06044103 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-21

No results posted yet for this study

Summary

The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women who undergoes examination and repair of obstetric perineal lacerations (grade I and II) are randomized into two arms (1:1); analgesia with pudendal nerve block (PNB) with ropivacaine (clinical routine, control group), or analgesia with PNB in combination with patient-controlled sedation with propofol (PCS, PCS group). The hypothesis is that PNB in combination with PCS improves patient experienced pain/discomfort during the examination and repair of the perineal laceration. The primary endpoint is patient experienced pain/discomfort. Secondary endpoints are time of repairing the perineal laceration, ability to have skin-to-skin contact with the baby during perineal repair, time until micturition after the perineal repair, procedure feasibility, amount of drugs used during perineal repair, and use of pain relief 24h postpartum. The study is planned to start during the second half of 2023 and end during the first half of 2024.

Conditions

  • Pain
  • Patient Satisfaction

Interventions

DRUG

PDB + PCS

Pudendal nerve block (PNB) with ropivacaine AND Patient-controlled sedation with propofol by the participant

Sponsors & Collaborators

  • Marie Blomberg

    lead OTHER_GOV

Principal Investigators

  • Linda Hjertberg, MD · Department of Obstetrics and Gynecology, Vrinnevi Hospital, Sweden.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-05-30
Completion
2024-10-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT06044103 on ClinicalTrials.gov