Patient-controlled sedation during repair of obstetric perineal lacerations

Start 19 Sep 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol PROP(ofol)

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 80

Countries 1

Sites 1

Obstetric perineal lacerations

To investigate patient pain/discomfort and complications when patient-controlled sedation with propofol is added to standard routine with pudendal nerve block during repair of obstetrical perineal lacerations grade I and II.

Key facts

Sponsor: Region Oestergoetland
Participant type: Patients
Age range: 18-64 years
Gender: Female
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration: 19 Sep 2023 → ongoing
Decision date (initial): 2023-03-29
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Conditions and MedDRA coding

Obstetric perineal lacerations

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Participation Patients will be included in the study after obtaining all the information necessary to understand the study. The investigator will explain to the patient the purpose of the study, its methodology, the expected benefits and risks of the treatments. The written and informed consent of the patient, if obtained, must be dated and signed both by the patient and the investigator before any further study assessment. The first and the last patient for the trial will be recruited, respectively, in XXXX 2023 and XXXX 2023. Eligible patients will be allocated to either the control group or intervention group (1:1) according to a computer generated randomisation list provided by a licensed and independent study monitor.	Randomised Controlled	None		Control group: Pudendal Nerve Block Intervention group: Pudendal Nerve Block and PCS with propofol

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Pain/discomfort (perprocedural)

Secondary endpoints 12

Preprocedural anxiety
Time of repair the perineal laceration
Ability to have skin-to-skin contact with baby during perineal repair
Time until micturition after the perineal repair
Procedure feasibility
Amount of drugs used during perineal repair
Use of pain relief 24h postpartum
Patient experience after repair of perineal laceration 4 days postpartum
Need of pain-relieving within 24 h postpartum
Time to mobilisation of the patient
Time to micturition
Perprocedural anxiety

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

—

SCP258842 · ATC

Route of administration: INTRAVENOUS BOLUS USE
Max daily dose: 500 mg milligram(s)
Max total dose: 500 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01AX10 — PROPOFOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 4

Mepivacaine Hydrochloride

SCP1978687 · ATC

Active substance: Mepivacaine Hydrochloride
Substance synonyms: CARBOCAINE HYDROCHLORIDE
Route of administration: INJECTION
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB53 — MEPIVACAINE, COMBINATIONS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Anhydrous Lidocaine Hydrochloride

SCP47394575 · ATC

Active substance: Anhydrous Lidocaine Hydrochloride
Route of administration: TOPICAL
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB02 — LIDOCAINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Anhydrous Ropivacaine Hydrochloride

SCP1698700 · ATC

Active substance: Anhydrous Ropivacaine Hydrochloride
Route of administration: INJECTION
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB09 — ROPIVACAINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mepivacaine Hydrochloride

SCP265737 · ATC

Active substance: Mepivacaine Hydrochloride
Substance synonyms: CARBOCAINE HYDROCHLORIDE
Route of administration: INJECTION
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: N01BB03 — MEPIVACAINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oestergoetland

Sponsor organisation: Region Oestergoetland
Address: S S:t Lars, S:t Larsgatan 49 B, Linkopings S:t Lars S:t Larsgatan 49 B Linkopings S:t Lars
City: Linkoping
Postcode: 582 24
Country: Sweden

Scientific contact point

Organisation: Region Oestergoetland
Contact name: Linda Hjertberg

Public contact point

Organisation: Region Oestergoetland
Contact name: Linda Hjertberg

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ongoing, recruiting	80	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ongoing, recruiting

Vrinnevisjukhuset I Norrkoeping - Region Oestergoetland

Obstetrics and Gynecology, Women's Clinic, Children's and Women's, S Borg, Gamla Ovagen 25, Norrkoping

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2023-09-19		2023-09-19

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2022-12-16	Sweden	Acceptable 2023-03-22	2023-03-29