Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations

NCT06044103 | Unknown Phase 4 DMC

• 2 other identifiers: PROP(ofol)2022-502292-39
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obstetric perineal lacerations; patient-controlled sedation; propofol

Outcome Measures

Primary Outcomes (1)

• Pain/discomfort (perprocedural)

  Perprocedural pain/discomfort; is a composite variable consisting measurements of pain and discomfort: Pain; measured with a VAS-scale (0-100 mm, "No pain" to "Worst imaginable pain") Discomfort; measured with a VAS-scale (0-100 mm, "No discomfort" to "Worst imaginable discomfort").

  From randomization up to 2 hours. Measuring starts when the procedure with examination and repair of the laceration starts. Evaluation will be done immediately after procedure when criteria of fully recovered (OAA/S 5) is fulfilled.

Secondary Outcomes (10)

• Preprocedural anxiety

  From randomization up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).

• Perprocedural anxiety

  From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).

• Patient experiences

  From randomization Up to 2 hours. Evaluation will be done once in connection to completion of the procedure after fulfilling the criteria of fully recovered (OAA/S 5).

• Time of repair the perineal laceration

  From randomization Up to 2 hours. Time for the procedure, the time between first attempt to suture until last suture.

• Ability to have skin-to-skin contact with baby during perineal repair

  From randomization Up to 2 hours. The evaluation is made immediately after procedure completion.

Other Outcomes (6)

• Peripheral capillary oxygen saturation

  After randomization, From time to event. Recorded every five minutes during the procedure by monitoring oxygen saturation.

• Respiratory frequency

  After randomization,From time to event. Recorded every five minutes during the procedure by monitor Philips Intellivue MX700 and InterlliVueX3.

• Non-invasive blood pressure

  After randomization,From time to event. Recorded every five minutes during the procedure with monitor Philips Intellivue MX700 and IntelliVue X3.

Study Arms (2)

Control

NO INTERVENTION

Clinical routine

Patient-controlled sedation with propofol

EXPERIMENTAL

PCS group

Drug: PDB + PCS

Interventions

PDB + PCS DRUG

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

Patient-controlled sedation with propofol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females after labor
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marie Blomberg: lead

Study Sites (1)

Vrinnevihospital

Norrköping, Sweden

RECRUITING

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Linda Hjertberg, MD

  Department of Obstetrics and Gynecology, Vrinnevi Hospital, Sweden.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Hjertberg, MD

CONTACT

+4610-104 26 03; linda.hjertberg@regionostergotland.se

Benjamin Grossmann, PhD

CONTACT

benjamin.grossmann@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Obstetrics and Gyneacology

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 21, 2023
• Study Start: September 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: October 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The supporting information will be available from november 2025 until 6 months after publication
• Access Criteria: Requests for sharing IPD that underlie results in a publication can be made to the principal investigator.

Locations

SE (1)