Clinical trial • Phase IV • Other

MAGNESIUM SULFATE for Postoperative pain

Phase IV trial of MAGNESIUM SULFATE for Postoperative pain.

Overview

Trial Therapeutic Area: Other
Trial Disease: Postoperative pain
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 27-11-2024
First CTIS Authorization Date: 17-03-2025

Trial design

Randomised, control: 100 ml natriumchloride (sodium chloride) 0.9% given intravenously over 30 minutes. Phase IV trial across 1 site in Sweden.

Randomised: Yes
Comparator: Control: 100 ml natriumchloride (sodium chloride) 0.9% given intravenously over 30 minutes.
Target Sample Size: 150
Trial Duration For Participant: 90

Eligibility

Recruits 150 Vulnerable population: pregnant/newly delivered women are the target population; participants must be adults (≥18) and able to understand information in Swedish. Informed consent must be provided by the participant (no assent or surrogate consent procedures are described)..

Vulnerable Population: Vulnerable population: pregnant/newly delivered women are the target population; participants must be adults (≥18) and able to understand information in Swedish. Informed consent must be provided by the participant (no assent or surrogate consent procedures are described).

Inclusion criteria

{"criterion_text":"- Adult over age 18."}
{"criterion_text":"- Cesarean section under spinal anesthesia."}
{"criterion_text":"- Participant should be able to accomodate information in Swedish"}

Exclusion criteria

{"criterion_text":"- Cronic kidney desease stadium 3 or above."}
{"criterion_text":"- Not Swedish speaking."}
{"criterion_text":"- Contraindication towards spinal anesthesia."}
{"criterion_text":"- General anesthesia"}

Endpoints

Primary endpoints

{"endpoint_text":"- Acute postoperative pain within 6 hours","definition_or_measurement_approach":"Acute postoperativ smärta (NRS). Högst smärtintensitet inom 6 timmar postoperativt jämförs mellan grupperna."}

Secondary endpoints

{"endpoint_text":"- Acute postoperative pain after 14 days, in both rest and movement.","definition_or_measurement_approach":"Akut postoperativ smärta (NRS). Högst smärtintensitet de senaste 24 timmarna, i vila och rörelse, 14 dagar postoperativt."}
{"endpoint_text":"- Acute postoperative pain after 24 hours, in both rest and movement","definition_or_measurement_approach":"Akut postoperativ smärta (NRS). Högst smärtintensitet, i vila och rörelse, de första 24 timmar postoperativt jämförs mellan grupperna."}
{"endpoint_text":"- Persistent postoperative pain after 3 months in both rest and movement.","definition_or_measurement_approach":"Persisterande postoperativ smärta (NRS). Högst smärtintensitet de senaste 24 timmarna, i vila och rörelse, 3 månader postoperativt"}
{"endpoint_text":"- Early recovery after 24 hours","definition_or_measurement_approach":"Tidig återhämtning (Quality of Recovery, 15 item). Totalpoäng de första 24 timmarna postoperativt jämförs mellan grupperna."}
{"endpoint_text":"- Early recovery after 14 days.","definition_or_measurement_approach":"Tidig återhämtning (Quality of Recovery, 15 item). Totalpoäng efter 14 dagar, postoperativt jämförs mellan grupperna"}
{"endpoint_text":"- Opioidconsumption. Total opioid dose in intravenous morphine milligram equivalents after 24 hours.","definition_or_measurement_approach":"Opioidkonsumption (intravenöpsa morfinekvivalenter). Total mängd intravenösa morfinekvivalenter i milligram under de första 24 timmarna jämförs mellan grupper."}
{"endpoint_text":"- Postoperative nausea and vomiting. Highest intensity after 24 hours.","definition_or_measurement_approach":"Opioidkonsumption (intravenöpsa morfinekvivalenter). Total mängd intravenösa morfinekvivalenter i milligram under de första 24 timmarna jämförs mellan grupperna."}
{"endpoint_text":"- Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 24 hours.","definition_or_measurement_approach":"Självskattad amningskvalité respektive anknytning (NRS). Maxpoäng avseende självskattad amningskvalité respektive anknytning till det nyfödda barnet de första 24 timmarna jämförs mellan grupperna."}
{"endpoint_text":"- Self-evaluated quality of breastfeeding and fetal connection. Highest score between 0 and 10 is compared between groups after 14 days.","definition_or_measurement_approach":"Självskattad amningskvalité respektive anknytning (NRS). Maxpoäng avseende självskattad amningskvalité respektive anknytning till det nyfödda barnet efter 14 dagar, jämförs mellan grupperna."}

Recruitment

Planned Sample Size: 150
Recruitment Window Months: 18
Consent Approach: Informed consent must be provided by the adult participant (≥18). Participants must be able to understand information in Swedish. A Subject information and informed consent form document is listed (Information till forsoksperson MAG-PAIN). No assent or surrogate consent procedures are described.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 150

Sweden

Earliest CTIS Part Ii Submission Date: 01-03-2025
Latest Decision Or Authorization Date: 17-03-2025
Processing Time Days: 16
Number Of Sites: 1
Number Of Participants: 150

Sites

Site Name: Region Halland
Department Name: Anesthesia and Intensive care
Contact Person Name: Anna Persson
Contact Person Email: anna.p.persson@regionhalland.se

Sponsor

Primary sponsor

Full Name: Region Halland
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Sweden

Investigational products

Investigational Product Name: MAGNESIUM SULFATE
Active Substance: MAGNESIUM SULFATE
Modality: Small molecule
Routes Of Administration: IV INFUSION
Route: IV INFUSION
Starting Dose: 20 mmol in 100 ml sodium chloride 0.9% given intravenously over 30 minutes
Dose Levels: 20 mmol
Frequency: Single perioperative IV infusion
Maximum Dose: 20 mmol

Investigational Product Name: Sodium chloride 0.9% (solvent control)
Active Substance: Sodium chloride
Modality: Small molecule
Routes Of Administration: IV INFUSION
Route: IV INFUSION
Starting Dose: 100 ml sodium chloride 0.9% given intravenously over 30 minutes
Dose Levels: 100 ml
Frequency: Single perioperative IV infusion
Maximum Dose: 100 ml

Related trials

Other published trials that may interest you.