Comparison of spinal anesthesia using levo-bupivacaine of 3 different densities to see which one works best for pain relief and recovery after surgery.

Comparison of quality and recovery profile of subarachnoid block using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levo-bupivacaine : a double blind randomized comparative study. - -

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084807

Enrollment

105

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: N433- Hydrocele, unspecified Health Condition 2: N471- Phimosis Health Condition 3: N452- Orchitis Health Condition 4: N453- Epididymo-orchitis Health Condition 5: K353- Acute appendicitis with localizedperitonitis Health Condition 6: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 7: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 8: N210- Calculus in bladder Health Condition 9: N211- Calculus in urethra Hea

Interventions

Intervention1: Subarachnoid block given using isobaric 0.5% levobupivacaine: On arrival of the patient in the operating room, intravenous access was obtained in the upper limb with 18G cannula and a p

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA Grade I and II patients. 2. Patients posted for below umbilical elective surgeries. 3. Age between 18 years to 65 years. 4. BMI 17-30 kg/m2 5. Patients of all genders.

Exclusion criteria

Exclusion criteria: 1. Patient refusal for procedure. 2. Any bleeding disorder or patient on anticoagulants. 3. Surgeries prolonging more than 3 hrs. 4. Pregnant and lactating females. 5. Patients with failed spinal anaesthesia. 6. History of drug allergy. 7. Local infection at the injection site.

Design outcomes

Primary

Measure	Time frame
To compare the highest level of sensory block achieved, the onset & duration of motor block achieved and the recovery from subarachnoid block given by using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levobupivacaine.Timepoint: 1. Time of subarachnoid block administration. 2. Sensory block onset (time taken to reach T10 level). 3. Sensory block duration (2 segment regression of sensory level). 4. Motor block onset (time taken to reach modified bromage score 3). 5. Motor block duration (time taken in regression of modified bromage score to 0.	—

Measure

Time frame

To compare the highest level of sensory block achieved, the onset & duration of motor block achieved and the recovery from subarachnoid block given by using either 0.5% hyperbaric, 0.5% isobaric or sequential hyperbaric followed by isobaric levobupivacaine.Timepoint: 1. Time of subarachnoid block administration. 2. Sensory block onset (time taken to reach T10 level). 3. Sensory block duration (2 segment regression of sensory level). 4. Motor block onset (time taken to reach modified bromage score 3). 5. Motor block duration (time taken in regression of modified bromage score to 0.

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Secondary

Measure	Time frame
To assess intraoperative hemodynamics [Heart Rate(HR), Blood Pressure(BP), Mean Arterial Pressure(MAP), oxygen saturation(SpO2), Temperature].Timepoint: At rest, 1min., 5min., 10min., 15min., 30min., 60min., 90min., 120min.;To assess postoperative pain score using Visual Analogue Scale (VAS) score.Timepoint: At rest, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour.;To assess the time of first rescue analgesia (when VAS score is more than 4).Timepoint: Time at which 1st analgesic was required postoperatively.;To assess any adverse events related to subarachnoid block.Timepoint: For 24 hrs following surgery.	—

Measure

Time frame

To assess intraoperative hemodynamics [Heart Rate(HR), Blood Pressure(BP), Mean Arterial Pressure(MAP), oxygen saturation(SpO2), Temperature].Timepoint: At rest, 1min., 5min., 10min., 15min., 30min., 60min., 90min., 120min.;To assess postoperative pain score using Visual Analogue Scale (VAS) score.Timepoint: At rest, 2nd hour, 4th hour, 8th hour, 12th hour, 16th hour, 24th hour.;To assess the time of first rescue analgesia (when VAS score is more than 4).Timepoint: Time at which 1st analgesic was required postoperatively.;To assess any adverse events related to subarachnoid block.Timepoint: For 24 hrs following surgery.

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Countries

India

Contacts

Public ContactDr Mangilal Deganwa

Mahatma Gandhi Medical College and Hospital

mangilaldeganwa0606@gmail.com9871495240

Outcome results

None listed

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