Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
150
Countries
1
Sites
1
Postoperative pain
The aim in this study is to investigate if adding intravenous magnesium-sulfate to pregnant women undergoing cesarean section can lead to improved postoperative pain outcomes.
Key facts
- Sponsor
- Region Halland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-03-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Region Halland
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The aim in this study is to investigate if adding intravenous magnesium-sulfate to pregnant women undergoing cesarean section can lead to improved postoperative pain outcomes.
Secondary objectives 6
- Investigate the incidense of acute postoperative pain after 24 hours and 14 days postoperatively and compare these between groups.
- Investigate early recovery after 24 hours and 14 days postoperatively and compare these between groups.
- Investigate total opioid consumption after 24 hours postoperatively and compare these between groups.
- Investigate incidence of postoperative nausea and vomiting after 24 hours postoperatively and compare these between groups.
- Investigate the incidence of persistent postoperative pain after 3 months postoperatively and compare these between groups.
- Investigate the difference in quality of breast-feeding and fetal connection after 24 hours and 14 days postoperatively and compare these between groups.
Conditions and MedDRA coding
Postoperative pain
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Magnesiumsulphate for Postoperative Analgesia In the Newly delivered Investigate if magnesiumsulphate can reduce acute postoperative pain in pregnant women undergoing cesarean section
|
Randomised Controlled | Single | [{"id":112953,"code":2,"name":"Investigator"},{"id":112954,"code":1,"name":"Subject"}] | Intervention: Adding 20 mmol Magnesiumsulphate in 100 ml natriumchloride 0.9%, given intravenously during 30 minutes Control: Adding 100 ml natriumchloride 0.9% during 30 minutes. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult over age 18. Cesarean section under spinal anesthesia. Participant should be able to accomodate information in Swedish
Exclusion criteria 1
- Cronic kidney desease stadium 3 or above. Not Swedish speaking. Contraindication towards spinal anesthesia. General anesthesia
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Acute postoperative pain within 6 hours
Secondary endpoints 9
- Acute postoperative pain after 14 days, in both rest and movement.
- Acute postoperative pain after 24 hours, in both rest and movement
- Persistent postoperative pain after 3 months in both rest and movement.
- Early recovery after 24 hours
- Early recovery after 14 days.
- Opioidconsumption. Total opioid dose in intravenous morphine milligram equivalents after 24 hours.
- Postoperative nausea and vomiting. Highest intensity after 24 hours.
- Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 24 hours.
- Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 14 days.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP12571209 · ATC
- Active substance
- Magnesium Sulfate
- Substance synonyms
- DRIED MAGNESIUM SULPHATE, MAGNESIUM SULPHATE, MAGNESII SULFAS
- Route of administration
- IV INFUSION
- Max daily dose
- 20 mmol millimole(s)
- Max total dose
- 20 mmol millimole(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA05 — MAGNESIUM SULFATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
-
V07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- IV INFUSION
- Max daily dose
- 100 ml millilitre(s)
- Max total dose
- 100 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Halland
- Sponsor organisation
- Region Halland
- Address
- Sodra Vagen 9
- City
- Halmstad
- Postcode
- 302 38
- Country
- Sweden
Scientific contact point
- Organisation
- Region Halland
- Contact name
- Krister Mogianos
Public contact point
- Organisation
- Region Halland
- Contact name
- Krister Mogianos
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokoll klinisk provning MAG-PAIN | 2 |
| Recruitment arrangements (for publication) | Rekrytering och samtycke - MAG-PAIN | 2 |
| Subject information and informed consent form (for publication) | Information till forsoksperson MAG-PAIN | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Addex-Magnesium | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Natriumklorid | 1 |
| Synopsis of the protocol (for publication) | Synopsis MAG-PAIN | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-27 | Sweden | Acceptable 2025-03-17
|
2025-03-17 |