Effect of Intravenous Magnesiumsulfate on Postoperative Pain in Patients Undergoing Cesarean Section: The Magnesium for Postoperative Analgesia In the Newly Delivered, The MAG-PAIN Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Acute postoperative pain (APOPmax6h)
研究概览
简要总结
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.
详细描述
Background:
Caesarean section is one of the most common surgical procedures worldwide, and the number performed continues to rise. Even with improvements in surgery and modern perioperative care, managing pain after a Caesarean section remains a major challenge. Severe postoperative pain can slow a mother's recovery and make it harder to bond with her baby or begin breastfeeding. Good pain control is important not only for comfort but also to prevent complications such as delayed movement, blood clots, and breathing problems. Post-Caesarean pain has many possible causes, involving both tissue-related (nociceptive) and nerve-related (neuropathic) components, which means pain management often needs to be tailored to each individual.
Magnesium has been used in obstetrics for many years because of its medical benefits. It is commonly given to prevent or treat eclamptic seizures and to protect premature babies from brain injury. It can also stabilise blood pressure in pregnancy-related hypertension. Although its exact pain-relieving mechanism is not fully understood, magnesium is believed to reduce pain by influencing calcium movement in cells and by blocking NMDA receptors, which play a role in pain signalling.
Some studies suggest that magnesium may help reduce pain after surgery. However, there are currently no official recommendations for its use specifically during Caesarean sections.
This study aims to determine whether giving magnesium intravenously during planned Caesarean sections can improve postoperative pain and recovery. The study also examines whether magnesium leads to reduced opioid use and lower rates of nausea and vomiting after surgery. The researchers hypothesise that magnesium will be superior to standard care for both the primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Planned or non-urgent c-section in regional anesthesia
- •Ability to read, speak and understand infromation in Swedish
- •Oral and written consent
排除标准
- •Contraindications for spinal anesthesia
- •Moderate to severe kidney failure
- •Need of translator
- •Ongoing treatment with magnesium-infusion
- •Myastenia Gravis
研究组 & 干预措施
Magnesium
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.
干预措施: Magnesium group (Drug)
Placebo
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Acute postoperative pain (APOPmax6h)
时间窗: Within the first 6 hours after surgery
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)
次要结局
- 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)
- Family A - 3. Self-efficacy score(Measured at 24 hours after surgery)
- Family A - 4. Opioid consumption(Measured at 24 hours after surgery)
- Family A - 5. Adverse events(Measured at 24 hours after surgery)
- Family B - 1. Pain interference score(Measured at 48 hours after surgery)
- Family B - 2. Self-efficacy score(Measured at 48 hours after surgery)
- Family B - 3. Opioid consumption(Measured at 48 hours after surgery)
- Family B - 4. Adverse events(Measured at 48 hours after surgery)
- Family C - 1. Pain interference score(Measured at 72 hours after surgery)
- Family C - 2. Self-efficacy score(Measured at 72 hours after surgery)
- Family C - 3. Opiod consumption(Measured at 72 hours after surgery)
- Family C - 4. Adverse events(Measured at 72 hours after surgery)
- Family D - 1. Average subactue postoperative pain(Measured 14 days after surgery)
- Family D - 2. Worst subacute postoperative pain(Measured 14 days after surgery)
- Family E - 1. Average persistent postoperative pain(Measured 90 days after surgery)
- Family E - 2. Worst persistent postoperative pain(Measured 90 days after surgery)
- Family E - 3. Pain interference score(Measured 90 days after surgery)
- Family E - 4. Self-efficacy score(Measured 90 days after surgery)