NCT06446830|Recruiting
Loading search results
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 25, 2024
Actual (reported)Primary Completion
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2024
Actual (reported)June 2, 2024
Actual (reported)June 6, 2024
Actual (reported)November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
quality of recovery on discharge from ICU
on discharge from ICU ( or within 48 hours post operative ) which is shorter
occurrence of any side effects
during ICU stay and no more than 48 hours post-caesarean section
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
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
B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
Routine Paracetamol and NSAID
Ain shams university
Cairo, Egypt, 11591, Egypt
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.
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.
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.
wessam selima, MD
assistant professor (lecturer)- Ain shams university
First Submitted
June 2, 2024
First Posted
June 6, 2024
Study Start
May 25, 2024
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 17, 2025
Record last verified: 2025-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: