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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin B | Experimental | oral vitamin B complex tablets preoperative and continue post-operative for 2 days One tablet oral once daily for 1- 2 days according to the length of stay; the tablet is a vitamin (B1, B6, B9, and B12). Oral daily vitamin B concentration; Tablet is composed of ; B1= 250mg, B6= 150 mg, B12= 0,250 mg, B9= 0.5mgm, B2 15 mg standard analgesic ladder will be implemented in the form of; Paracetamol 1gram (2 tablets) / 8hr for 48 hours, Ketorolac 30 mg / 12 hour for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented. the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage |
|
| standard | Active Comparator | patients will receive a preoperative; Oral placebo tablet (once/day) Post-operative and continue post-operative for 2 days; One placebo capsule oral once daily for 2 days. standard analgesic ladder will be implemented in the form of; Paracetamol 1 gram (2 tablets) / 8hr for 48 hours. Ketorolac / 12 hours for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented. the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal analgesia and vitamin B | Drug | B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total consumption of rescue analgesics in the first and second 24 hours after delivery | the difference in mean of the total amount consumed of paracetamol, ketorolac and nalbuphine | 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. | By using a s scale from 0-10 where zero is no pain and 10 is the worst pain, the scale willbe used 24 hours postoperative . results will be compared between both groups | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| quality of recovery on discharge from ICU | using The Obstetric Quality of Recovery-10A questionnaire where less than 70 will be considered poor recovery , and the higher the score will be linked to better recovery | on discharge from ICU ( or within 48 hours post operative ) which is shorter |
| occurrence of any side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wessam selima, MD | Contact | 01001958858 | w.z.selima@med.asu.edu.eg | |
| wessam Z mohamed | Contact | 01003069492 | w.z.selima@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| wessam selima, MD | assistant professor (lecturer)- Ain shams university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Recruiting | Cairo | Egypt | 11591 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35496649 | Background | 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. | |
| 28379583 | Background | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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two parallel-group, randomized, double-blinded
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the candidate will be masked, and Assessments regarding the primary outcome will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program
| standard multimodal analgesia | Drug | Routine Paracetamol and NSAID |
|
occurrences of any side effects as allergy |
| during ICU stay and no more than 48 hours post-caesarean section |
| 36852448 | Background | 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. |
| 30531087 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D006571 | Heterocyclic Compounds |