The Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section

Официальное название

The Analgesic Efficacy of Vitamin B Complex with Paracetamol and Non-steroidal Antiinflammatory Medication in Critically Ill Obstetrics After Caesarian Section; a Prospective Randomized , Placebo-controlled and Double-blinded Study

Обзор

We aim to investigate the value of vitamin B (B1, B6, B9, B12) on post-cesarean section analgesia in addition to the standard opioid-sparing multimodal regimen to achieve more robust analgesia with minimal side effects.

Подробное описание

Optimum analgesia is an essential component in enhanced recovery after elective and emergency Caesarean section. Opioid-based analgesia negatively affects maternal functional recovery. Unlike other types of surgeries, the performance and the quality of postoperative recovery in caesarean section affects two individuals: the patient and their infant, hence it is recommended to use Opioid-sparing medications post-caesarean section.

Multimodal analgesia is recommended for post-caesarean section pain control. The main properties of its components are to promote return of (i) Mobility (ii) Oral intake (iii) Normal bowel function (iv) Micturition: Trial without urinary catheter (v) Activities of daily living, with Few adverse effects: inactive metabolites (no nausea, vomiting, sedation, pruritus, constipation or respiratory depression), Readily available after discharge home, Little risk of dependency (especially long-term opioids), Minimal risk of hyperalgesia or chronic pain and cost-efficient with minimally invasive technique and no side-effects on the neonate.

The morbidity of critically ill obstetrics can increase due to inadequate control of pain and also due to the consumption of opioid analgesia due to associated respiratory depression, sedation, and nausea. Multimodal analgesia is strongly recommended.

An immune-histochemistry study found that B vitamins potentiate acute morphine antinociception. In other studies, the value of vitamin B complex on postoperative analgesia was discussed and investigated in different combinations Another study reported the value of folic acid in decreasing gastric hypersensitivity in maternal stress in rats. Other studies explained the benefit of folic acid in analgesia through modulating gut microbiota, reducing inflammation, modulating purinergic signaling, and promoting nerve repair (6)This is the first study to investigate the effect of vitamin B9 (folic acid ) and other vitamin B (B1, B6, B12) beside the standard opioid sparing analgesics on post-caesarean section pain in critically ill obstetrics.

Вмешательства

• Препарат multimodal analgesia and vitamin B
  B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
• Препарат standard multimodal analgesia
  Routine Paracetamol and NSAID

Первичные конечные точки

• The total consumption of rescue analgesics in the first and second 24 hours after delivery [Срок оценки: in the first 24 hours and in the second 24 hours (if stay is extended )]
• Pain score assessed by numerical pain scale after 24 hours from delivery. [Срок оценки: 24 hours postoperative]

Вторичные конечные точки (2)

• quality of recovery on discharge from ICU [Срок оценки: on discharge from ICU ( or within 48 hours post operative ) which is shorter]
• occurrence of any side effects [Срок оценки: during ICU stay and no more than 48 hours post-caesarean section]

Критерии участия

Критерии включения

• Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia.

Критерии исключения

• Patient's Refusal to participate
• Known allergy to one or more of the given components.
• Disturbed conscious level.
• Prolonged or complicated surgery; defined by operative time of more than 90 min.
• Severe liver dysfunction or failure
• Severe renal dysfunction or failure.
• Severe thrombocytopenia; platelets less than 50

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ain shams university — Cairo

Публикации

• Neall G, Bampoe S, Sultan P. Analgesia for Caesarean section. BJA Educ. 2022 May;22(5):197-203. doi: 10.1016/j.bjae.2021.12.008. Epub 2022 Mar 8. No abstract available. PMID 35496649
• Deng XT, Han Y, Liu WT, Song XJ. B Vitamins Potentiate Acute Morphine Antinociception and Attenuate the Development of Tolerance to Chronic Morphine in Mice. Pain Med. 2017 Oct 1;18(10):1961-1974. doi: 10.1093/pm/pnw358. PMID 28379583
• Wang HJ, Zhang FC, Xu TW, Xu YC, Tian YQ, Wu YY, Xu JT, Hu S, Xu GY. DNMT1 involved in the analgesic effect of folic acid on gastric hypersensitivity through downregulating ASIC1 in adult offspring rats with prenatal maternal stress. CNS Neurosci Ther. 2023 Jun;29(6):1678-1689. doi: 10.1111/cns.14131. Epub 2023 Feb 27. PMID 36852448
• Kang WB, Chen YJ, Lu DY, Yan JZ. Folic acid contributes to peripheral nerve injury repair by promoting Schwann cell proliferation, migration, and secretion of nerve growth factor. Neural Regen Res. 2019 Jan;14(1):132-139. doi: 10.4103/1673-5374.243718. PMID 30531087

Идентификаторы

NCT: NCT06446830 · FMASU R370/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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