Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperbaric Bupivacaine HCl 0.5% 12.5 mg, Hyperbaric Bupivacaine HCl 0.5% 10 mg.
- Who it may be relevant to
- Registry conditions: Cesarean Section Complications. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
Detailed description
This an interventional study comparing effect of Standard dose of Hyperbaric bupivacaine with 20% reduction of dose of Hyperbaric Bupivacaine in Elective Cesarean Delivery.
First, we determaine if the patient ( low - moderate - high ) risk to High spinal complication or not according to : Age-weight-BMI-Height.
Then , Randomly we gave the patients " Full dose of Hyperbaric Bupivacaine OR 20% reduction of hyperbric Bupivacaine " in spinal anaethsia .
Post anesthesia evaluation:
to assess incomplete sensory and/or motor blockade after spinal anesthesia for cesarean section is the Bromage Scale for motor blockade and a sensory block assessment using pinprick or cold sensation.
1. Bromage Scale for Motor Blockade:
This scale assesses the degree of motor block in the lower limbs: * Grade 0: No paralysis, full flexion of knees and feet. * Grade 1: Inability to raise extended legs; can move knees and feet. * Grade 2: Inability to flex knees; can move feet. * Grade 3: Complete paralysis of the lower limbs.
Incomplete motor blockade would typically be Bromage 1 or 2. 2. Sensory Block Assessment:
* Sensory block is often assessed using a pinprick test or cold sensation (ice or alcohol swab). * Levels are recorded using dermatome levels (T10, T6, T4, etc.). * Incomplete sensory block means failure to achieve adequate sensory block (T4-T6 for cesarean section), requiring additional analgesia or conversion to general anesthesia.
Interventions
- Drug Hyperbaric Bupivacaine HCl 0.5% 12.5 mg
1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl). - Drug Hyperbaric Bupivacaine HCl 0.5% 10 mg
2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).
Primary outcome measures
- 1-Reduced Incidence of HSB [Time frame: operation time]
- 1-Reduced Incidence of HSB [Time frame: first 20 minutes]
Eligibility criteria
Inclusion criteria
- • Pregnant women aged 18-45 years.
- ASA physical status II-III.
Exclusion criteria
- • Twin pregnancies.
- Contraindications to spinal anesthesia (e.g., coagulopathy, infection).
- Patients with incomplete preoperative data for risk stratification.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Aswan university — Aswān
Publications
- Benjhawaleemas P, Sakolnagara BBN, Tanasansuttiporn J, Chatmongkolchart S, Oofuvong M. Risk prediction score for high spinal block in patients undergoing cesarean delivery: a retrospective cohort study. BMC Anesthesiol. 2024 Nov 11;24(1):406. doi: 10.1186/s12871-024-02799-w. PMID 39528929
Identifiers
NCT: NCT07140640 · 1084-3-25