A randomized control trial to compare effectiveness and the safety of Isobaric (plain) Bupivacaine with Hyperbaric (heavy) Bupivacaine in patients undergoing caesarean sections.

Isobaric Bupivacaine versus Hyperbaric Bupivacaine for Spinal Anaesthesia in Caesarean sections: Prospective Randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2024/014

Enrollment

Unknown

Registered

2024-04-30

Start date

2024-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarian sections

Interventions

Study setting: This will be carried out as a single centre study at main operating theatre and obstetric wards at Teaching Hospital Peradeniya. Method of Randomization: Block randomization method w

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women undergoing elective caesarean section, above 18 years of age.

Exclusion criteria

Exclusion criteria: • Patients with functional disabilities- American Society of Anesthesiologists (ASA) grade 3 and 4. • Patients undergoing spinal anesthesia in different positions except sitting up position.

Design outcomes

Primary

Measure	Time frame
Time taken to achieve satisfactory level of anesthesia and the level of sensory block intra-operatively. [Intra-operative period] The duration of anesthesia (sensory block) - assessed by the time for the first pain post-operatively [Intra-operative period] The degree of cardiovascular stability (systolic blood pressure drop less than 20mmHg, heart rate variability of 60 to 100) and the respiratory rate of 10 to 20) will be considered normal and stable) [Intra-operative period]	—

Measure

Time frame

Time taken to achieve satisfactory level of anesthesia and the level of sensory block intra-operatively. [Intra-operative period] The duration of anesthesia (sensory block) - assessed by the time for the first pain post-operatively [Intra-operative period] The degree of cardiovascular stability (systolic blood pressure drop less than 20mmHg, heart rate variability of 60 to 100) and the respiratory rate of 10 to 20) will be considered normal and stable) [Intra-operative period]

—

Secondary

Measure	Time frame
Presence of non-specific complications such as shivering, abnormal sensations like “pins and needles”, itchiness, nausea & vomiting. [Intraoperative and post operative period]	—

Countries

Sri Lanka

Contacts

Public ContactDr Anura Abeysundara

Consultant Anaesthetist and Senior Lecturer

anuraabeysundara@gmail.com0715386224

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026