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. The participants 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.
Adult
Planned or non-urgent c-section in regional anesthesia
Ability to read, speak and understand infromation in Swedish
Oral and written consent
Contraindications for spinal anesthesia
Moderate to severe kidney failure
Need of translator
Ongoing treatment with magnesium-infusion
Parallel
Magnesium group
DrugWhen 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.
Placebo
DrugWhen 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.
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)
Worst APOP (NRS)
Pain trajectory over worst acute postoperative pain measured with NRS at repeated time-points (APOPmax12h, APOPmax24h, APOPmax48h, APOPmax72h). Comparison between interventional and placebo groups. (0 is equivalent to no pain and 10 indicates worst possible pain)
Average APOP (NRS)
Pain trajectory over average acute postoperative pain, during the previous 24 hours, measured with NRS at repeated time-points (APOPave24h, APOPave48h, APOPave72h). Comparison between interventional and placebo groups. (0 is equivalent to no pain and 10 indicates worst possible pain)
Current APOP (NRS)
Pain trajectory over current acute postoperative pain, at rest and during movement, measured with NRS at repeated time-points (APOPrest24h, APOPrest48h, APOPrest72h, APOPmove24h, APOPmove48h, APOPmove72h). Comparison between interventional and placebo groups. (0 is equivalent to no pain and 10 indicates worst possible pain)
Family A - 1. Quality of recovery
Family-wise key secondary outcomes - hierarchical based: 1\. QoR-15 score at 24 h (QoR24h). Self-reported on the scale with 15 questions each evaluated on an 11-point scale (0 = worst, 10 = best), resulting in a best possible score of 150.
Proportion with moderate to severe pain
Proportion of patients experiencing moderate to severe (NRS ≥ 4) worst and average self-reported postoperative pain at rest and during movement. Comparison between groups.
Proportion with persistent postoperative pain
Proportion of patients experiencing worst and average self-reported NRS ≥ 1 at 3 months. Comparison between groups.
Opioid consumption
Total opioid consumption (self-reported) expressed in intravenous morphine equivalents. Comparison between groups.
Infant-mother attachment (IMA24h, IMA48h, IMA72h)
Self-reported infant-mother attachment at 24 h, 48 h, 72 h (IMA24h, IMA48h, IMA72h). Comparison between groups.
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Region Halland
Lead sponsor
Lund University
Collaborator
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