To observe the effect of extension of epidural space with normal saline on the effect of spinal anaesthesia using low dose of local anaesthetic i.e., high density BUPIVACAINE in patients undergoing infraumbilical surgeries

A prospective, interventional study to evaluate the effect of epidural volume extension on the characteristics of subarachnoid block with low dose of hyperbaric bupivacaine in patients undergoing infraumbilical surgeries

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051776

Enrollment

Registered

2023-04-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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

Conditions

Health Condition 1: I839- Asymptomatic varicose veins of lower extremities Health Condition 2: S720- Fracture of head and neck of femur Health Condition 3: R103- Pain localized to other parts of lower abdomen

Interventions

Intervention1: Combined Spinal Epidural with Epidural Volume extension by 7.4mL Normal Saline: The Group II patients undergoing infraumbilacal surgeries under Subarachnoid block using low dose (10mg)

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) status Iâ??II 2. Belonging to both genders 3. Age - 18 years to 60 years 4. Type of Surgery â??Elective Infraumbilical surgeries under CSE 5. Valid written informed consent

Exclusion criteria

Exclusion criteria: 1. ASA • & â?£ 2. BMI > 30kg/m2 3. Height - 4. Patients with a history of spinal disease/deformities 5. Coagulation abnormality 6. Sensitivity to bupivacaine 7. Contraindications to central neuraxial block 8. Local infections 9. Patient refusal Post inclusion exclusion criteria: Patients with inadequate block who require epidural top ups with local anaesthetic at any time during the surgery

Design outcomes

Primary

Measure	Time frame
1. Maximum sensory dermatomal level achieved 2. Time taken for the achieving maximum sensory level after subarachnoid blockTimepoint: 3, 6, 9, 12, 15 minutes after Subarachnoid block	—

Secondary

Measure	Time frame
1. Time to achieve adequate blockade (Tadeq i.e T10) 2. Time taken to achieve desired motor block 3. Time for two segment regression 4. Time for Motor recovery 5. Heart rate (HR) 6. Systolic blood pressure (SBP) 7. Diastolic blood pressure (DBP) 8. Mean arterial pressure (MAP).Timepoint: 3, 6, 9, 12, 15, 30, 45, 60 minutes after Subarachnoid block	—

Countries

India

Contacts

Public ContactDr Harshitha Punna

ESIC Medical college and Hospital

dilipkum@gmail.com9866904000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026