Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
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.
Bromage Scale for Motor Blockade:
This scale assesses the degree of motor block in the lower limbs:
Incomplete motor blockade would typically be Bromage 1 or 2.
Sensory Block Assessment:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose of Hyberbaric Bupivacaine in Elective cesarean section | Active Comparator | 1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl). |
|
| Reduced dose group in Elective cesarean section | Active Comparator | 2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Bupivacaine HCl 0.5% 12.5 mg | Drug | 1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-Reduced Incidence of HSB | 1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension >30% below baseline). | operation time |
| 1-Reduced Incidence of HSB | 1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension >30% below baseline). | first 20 minutes |
Not provided
Not provided
Inclusion Criteria:
• Pregnant women aged 18-45 years.
Exclusion Criteria:
• Twin pregnancies.
pregnant females planned for elective cesarean section
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman Mahmoud Ismail, Resident | Contact | +201141431136 | emanmahmoud37@gmail.com | |
| Soudy Salah Hammad, consultant | Contact | +201014761523 | soudi.salah@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ayman Mohamdy Eldemerdash, consultant | Aswan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan university | Aswān | Aswan Governorate | 000 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39528929 | Background | 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. |
| Label | URL |
|---|---|
| Risk prediction score for high spinal block in patients undergoing cesarean delivery: a retrospective cohort study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Hyperbaric Bupivacaine HCl 0.5% 10 mg | Drug | 2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl). |
|
|