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Patient-controlled sedation during repair of obstetric perineal lacerations

Phase 1
Recruiting
Conditions
Obstetric perineal lacerations
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
CTIS2022-502292-39-00
Lead Sponsor
Region Oestergoetland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

Adult patient (=18 years), Planned examination and repair of perineal laceration grades I or II, The patient has after receiving verbal and written information about the study given her signed informed consent to participate

Exclusion Criteria

BMI > 35 (during first visit at the maternity care centre), Preeclampsia or hypertensive disease, Postpartum haemorrhage > 1000 ml, Known/suspected allergy or contraindication to any medication within the study, Functional disability in both hands which affect the possibility to operate the PCS device, Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device, Perineal laceration grade III-IV, Deviation from department guidlines regarding preopartive fasting

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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