Analgesia Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia. Exclusion Criteria: 1. Patient's Refusal to participate 2. Known allergy to one or more of the given components. 3. Disturbed conscious level. 4. Prolonged or complicated surgery; defined by operative time of more than 90 min. 5. Severe liver dysfunction or failure 6. Severe renal dysfunction or failure. 7. Severe thrombocytopenia; platelets less than 50 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain shams university | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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. — View Citation
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. — View Citation
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. Erratum In: BJA Educ. 2022 Nov;22(11):448. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) | |
Primary | Pain score assessed by The Brief Pain Inventory (Short Form) after 12 -24 hours from delivery. | Using the validated Arabic version; the score of the assessment will be done on 12 , 24 hours . the results will be compared among both groups | within 12 and 24 hours postoperative | |
Secondary | quality of recovery on discharge from ICU | using The Obstetric Quality of Recovery-10 questionnaire | on discharge from ICU ( or within 48 hours post operative ) which is shorter | |
Secondary | occurrence of any side effects | occurrences of any side effects as allergy | during ICU stay and no more than 48 hours post-caesarean section |
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