Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery

NCT07140640 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1084-3-25
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.

Conditions

Cesarean Section Complications

Keywords

cesarean-20% hyperbaric bupivacaine

Outcome Measures

Primary Outcomes (1)

• Incidence of high spinal block (HSB)

  The incidence of high spinal block (HSB), defined as the presence of both of the following criteria within 15 minutes of intrathecal drug administration: 1. Sensory block exceeding the T4 dermatome: * Assessed bilaterally using the pinprick test (with a 25-gauge blunt needle) and cold sensation (using an alcohol swab) * The upper sensory level was recorded as the most cephalad dermatome with complete loss of sensation to both pinprick and cold * A block was considered to have exceeded T4 if the loss of sensation was documented above the T4 dermatome (i.e., ≥ T3 or higher) on at least one side 2. Hemodynamic instability, defined as any of the following (thresholds informed by Klöhr et al., 2010, and Kinsella et al., 2018): * A decrease in systolic blood pressure (SBP) exceeding 30% below baseline (baseline SBP was defined as the mean of three preoperative measurements taken in the supine position with left uterine displacement)

  Within 15 minutes after intrathecal drug administration (assessed at 5, 10, and 15 minutes)

Secondary Outcomes (4)

• Predictive Performance of the Risk-Prediction Score

  From pre-randomization up to the end of the intraoperative observation period for high spinal block (HSB) (e.g., from baseline prior to spinal injection through discharge from the Post-Anesthesia Care Unit [PACU] / ~2 hours post-anesthesia).

• Neonatal Outcomes

  1 minute and 5 minutes after delivery

• Maternal Satisfaction

  4 to 6 hours postoperatively

• Hemodynamic Stability

  Intraoperatively, from spinal injection ($T_0$) through surgical completion (monitored at 1, 3, 5, 7, 10, 12, 15 minutes, and every 5 minutes thereafter; up to approximately 2 hours).

Study Arms (2)

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).

Drug: Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

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).

Drug: Hyperbaric Bupivacaine HCl 0.5% 10 mg

Interventions

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).

Also known as: Standard dose of hyperbaric bupivacaine

Standard dose of Hyberbaric Bupivacaine in Elective cesarean section

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).

Also known as: 20% reduced dose of hyperbaric bupivacaine

Reduced dose group in Elective cesarean section

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant females planned for elective cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18-45 years.
• ASA physical status II-III.

You may not qualify if:

• Twin pregnancies.
• Contraindications to spinal anesthesia (e.g., coagulopathy, infection).
• Patients with incomplete preoperative data for risk stratification.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan university

Aswān, Aswan Governorate, 000, Egypt

RECRUITING

Related Publications (1)

• 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 RESULT

Related Links

• Risk prediction score for high spinal block in patients undergoing cesarean delivery: a retrospective cohort study

Study Officials

• Ayman Mohamdy Eldemerdash, consultant

  Aswan University

  STUDY DIRECTOR

Central Study Contacts

Eman Mahmoud Ismail, Resident

CONTACT

+201141431136; emanmahmoud37@gmail.com

Soudy Salah Hammad, consultant

CONTACT

+201014761523; soudi.salah@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking Description A double-blind design is maintained throughout the trial to minimize performance and detection bias. Drug Preparation \& Allocation Concealment: An independent anesthetist not involved in patient management, intraoperative care, or postoperative data collection prepares all study medications in identical, unmarked, prefilled syringes according to the sequentially numbered, sealed opaque envelopes. Participant Blinding: Parturients remain masked to group allocation and syringe volume throughout their hospital stay. Care Provider Blinding: The anesthesia residents performing the subarachnoid block and the operating surgical team are blinded to the allocated dose. Syringes are visually indistinguishable (clear, colorless solutions). Outcomes Assessor Blinding: Independent outcome assessors who record sensory dermatome levels, motor blockade (Modified Bromage Scale), hemodynamic parameters, and incidence of high spinal block (HSB) remain strictly masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Model Details: Prospective, randomized, active-controlled, parallel-group trial stratified preoperatively using a 7-parameter weighted risk-prediction tool.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 25, 2025
• Study Start: September 15, 2025
• Primary Completion: September 15, 2026
• Study Completion: September 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

EG (1)