Patient-controlled sedation for repairing perineal lacerations after childbirth
Does Adding Patient-controlled Sedation With Propofol During Repair of Obstetric Perineal Lacerations Grade I and II Improve Patient Experiences - a Randomized Control Trial
PHASE4 · Linkoeping University · NCT06044103
This study is testing if women having stitches for perineal tears after childbirth feel less pain with a combination of a nerve block and self-controlled sedation compared to just the nerve block alone.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Linkoeping University (other gov) |
| Locations | 1 site (Norrköping) |
| Trial ID | NCT06044103 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of patient-controlled sedation using propofol in combination with a pudendal nerve block for women undergoing repair of obstetric perineal lacerations. A total of 80 participants will be randomly assigned to receive either standard care with a pudendal nerve block or the combination of the block with patient-controlled sedation. The primary focus is to assess pain and discomfort experienced during the procedure, while secondary outcomes include the feasibility of the procedure and the time taken for recovery. The study is conducted at Vrinnevihospital in Sweden, adhering to ethical guidelines.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 and older who are scheduled for examination and repair of grade I or II perineal lacerations.
Not a fit: Patients with grade III or IV perineal lacerations or those with contraindications to the medications used will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management and patient satisfaction during perineal repair after childbirth.
How similar studies have performed: While similar approaches have been explored, this specific combination of patient-controlled sedation and pudendal nerve block is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥18 years) * Planned examination and repair of perineal laceration * The patient has after receiving verbal and written information about the study given her signed informed consent to participate Exclusion Criteria: * Perineal laceration grade III-IV * BMI \> 35 (during first visit at the maternity care centre) * Deviation from department guidlines regarding preopartive fasting * 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
Where this trial is running
Norrköping
- Vrinnevihospital — Norrköping, Sweden (RECRUITING)
Study contacts
- Principal investigator: Linda Hjertberg, MD — Department of Obstetrics and Gynecology, Vrinnevi Hospital, Sweden.
- Study coordinator: Linda Hjertberg, MD
- Email: linda.hjertberg@regionostergotland.se
- Phone: +4610-104 26 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Patient Satisfaction, obstetric perineal lacerations, patient-controlled sedation, propofol