Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study

Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Bupivacaine; Drug: Bupivacaine and Dexmedetomidine

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: fatma ahmed abdelfatah, MD; Phone Number: 00201091921540; Email: drfatmaahmed86@gmail.com

Study Locations

• Egypt
  • Elqalyoubea,
    • Banhā, Elqalyoubea,, Egypt, 13511
      • Recruiting
      • Banha Faculity of Medicine
      • Contact: fatma ahmed abdelfatah, MD; Phone Number: 00201091921540; Email: drfatmaahmed86@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 ~ 35 years. (3) ASA physical status II ~ III

Exclusion Criteria:

1. Multiple pregnancies.
2. Cardiovascular disease(e.g., pre-eclampsia and hypertension).
3. Serious hepatic dysfunction (Child-Pugh class C).
4. serious renal dysfunction (undergoing dialysis before surgery).
5. History of alcohol or opioid addiction.
6. Contraindication to spinal anesthesia.
7. Refusing to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (B); will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.	Drug: Bupivacaine; patient will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.
Active Comparator: Group (BD); will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.	Drug: Bupivacaine and Dexmedetomidine; patient will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of sensory block	time taken from intrathecal injection to sensory regression to S1 dermatome.	after anesthesia up to 12 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the onset time of sensory block	time taken from intrathecal injection to the maternal feeling of lower extremities temperature increment or numbness	during 30 minutes after intrathecal injection
the onset time of motor block	time taken from intrathecal injection to MBS > 1	during 30 minutes after intrathecal injection
The recovery quality of parturients	ObsQoR-11, score from 0 to 10 in each term, where 0 = strongly agree and 10 = strongly disagree, the higher of the score, the higher of recovery quality	24 hours post-operatively

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: spinal anesthesia; bupivacaine; dexmetomedine; cessarian delivery
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Dexmedetomidine
• Other Study ID Numbers: RC 17-2-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No