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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06446830
Other study ID # FMASU R370/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2024
Est. completion date October 1, 2024

Study information

Verified date May 2024
Source Ain Shams University
Contact wessam selima, MD
Phone 01001958858
Email w.z.selima@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Egypt Ain shams university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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

Outcome

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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