MAG-PAIN - MAGnesium for Postoperative Analgesia In the Newly Delivered

NCT07528612 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MAG-PAIN24-01
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate whether a commonly used medicine, magnesium, can help reduce pain after a Caesarean section. A total of 150 participants will be included. Their usual medical care will not change, and participation is entirely voluntary. The purpose of the study is to determine whether magnesium can improve pain relief after surgery and support faster recovery and bonding with the newborn. Before the operation, potential participants will receive a text message containing a short questionnaire about their background and their expectations regarding postoperative pain. On the day of surgery, all patients will receive two intravenous lines as part of routine care. Those who participate in the study will be asked to rate how painful this insertion was on a scale from one to ten. They will then be randomly assigned to receive either magnesium or a saltwater solution through a 100 ml drip, which is administered after the baby is born. Neither participants nor the clinical staff will know which solution has been given, and no blood samples will be collected. After the procedure, participants will be asked several times about their pain level. During the first three days after the operation, each participant will receive one text message per day with a short questionnaire about their pain, general recovery, and early bonding with their newborn. Fourteen days after the operation, and again three months later, they will receive additional questionnaires similar to the earlier ones. Each questionnaire takes approximately five to seven minutes to complete, and no extra hospital visits are required. Magnesium can cause side effects, but the risks associated with the dose used in the study are low. The most common side effect is a brief burning sensation at the infusion site, which is not harmful. Magnesium is widely used in medical care, including in pregnant patients, and the study team considers the treatment safe. Because the medication is administered after birth, it does not affect the baby and does not increase risks during breastfeeding. All collected information will be handled securely and confidentially. Data will be coded so that individual participants cannot be directly identified, and only the research team will have access to the key linking codes to individuals. Participants have the right to access their data, request corrections, ask for deletion of their information, or limit how their data is used. The study has been approved by the Swedish Ethical Review Authority, and results will be published in a scientific journal without identifying any participant. No financial compensation is provided, but participants are covered by the usual patient and medication insurance. To ensure that the study is conducted correctly, authorized monitors or authorities may compare study data with medical records. These individuals must sign confidentiality agreements. By giving consent to participate, individuals allow this review. All data will be stored according to legal archiving requirements. Participation in the study is completely voluntary. Individuals may withdraw at any time, and if they do, their collected data will be deleted. Their medical care before, during, and after the operation will not be affected by their decision to participate or withdraw.

Conditions

Postoperative Pain; Quality of Recovery (QoR-15); Pain Prediction; Magnesium Sulfate; Pain Interference; Self-Efficacy

Keywords

Postoperative pain after Caesarean section; Postoperative core outcome set for postoperative pain; NMDA-antagonism

Outcome Measures

Primary Outcomes (1)

• Acute postoperative pain (APOPmax6h)

  Worst acute postoperative pain (APOPmax6h) measured with NRS. Comparison between interventional and placebo groups. (0 is equivalent to no pain and 10 indicates worst possible pain)

  Within the first 6 hours after surgery

Secondary Outcomes (22)

• Worst APOP (NRS)

  12-, 24- , 48- and 72 hours after surgery

• Average APOP (NRS)

  24-, 48- and 72 hours after surgery

• Current APOP (NRS)

  24-, 48- and 72 hours after surgery

• Family A - 1. Quality of recovery

  Measured at 24 hours after surgery

• Family A - 2. Pain interference score

  Measured at 24 hours after surgery

Other Outcomes (10)

• Proportion with moderate to severe pain

  6, 12, 24, 48 and 72 hours and 14 days after surgery

• Proportion with persistent postoperative pain

  Within the last 24 hours measured at 3 months after surgery

• Opioid consumption

  14 days and 90 days after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

When the neonate is delivered, the umbilical cord has been cut and uterotonic drugs has been administered, patients in the the control group will receive an infusion of 100 ml 0.9% natrium chloride in 30 minutes.

Drug: Placebo

Magnesium

EXPERIMENTAL

When the neonate is delivered, the umbilical cord has been cut and uterotonic drugs has been administered, patients in the intervention group will receive an infusion of 20 mmol magnesium sulphate heptahydrate in 100 ml 0.9 % natrium chloride in 30 minutes.

Drug: Magnesium group

Interventions

Magnesium group DRUG

When the neonate is delivered, the umbilical cord has been cut and uterotonic drugs has been administered, patients in the intervention group will receive an infusion of 20 mmol magnesium sulphate heptahydrate in 100 ml 0.9 % natrium chloride infor 30 minutes.

Magnesium

Placebo DRUG

When the neonate is delivered, the umbilical cord has been cut and uterotonic drugs has been administered, patients in the the control group will receive an infusion of 100 ml 0.9% natrium chloride in 30 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Planned or non-urgent c-section in regional anesthesia
• Ability to read, speak and understand infromation in Swedish
• Oral and written consent

You may not qualify if:

• Contraindications for spinal anesthesia
• Moderate to severe kidney failure
• Need of translator
• Ongoing treatment with magnesium-infusion
• Myastenia Gravis

Sponsors & Collaborators

• Region Halland: lead
• Lund University: collaborator

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Anna KM Persson, MD. PhD. Senior consultant

  Lund University Department in clinical sciences Malmö & Region Halland Department of Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krister Mogianos, MD

CONTACT

004635131000; krister.mogianos@med.lu.se

Anna KM Persson, MD. PhD

CONTACT

004635131000; anna.p.persson@regionhalland.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 14, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share