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To compare ropivacaine for spinal saddle block for two different sitting duration in fistula in ano surgery

Comparison of discharge readiness following fistula in ano surgery after one versus two minutes of saddle spinal block with hyperbaric ropivacaine

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049410
Enrollment
62
Registered
2023-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ropivacaine: 1.6 ml of 0.75% ropivacaine heavy given between L3-L4 space once and comparison is made with sitting duration of one versus two minutes for saddle block effect in patients

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA physical status I and II of either sex. 2. Age between 18 to 65 years. 3. BMI 20 to 35 kg/m2 4. Scheduled for FIA surgery.

Exclusion criteria

Exclusion criteria: 1. Refusal by the patient. 2. Patients with coagulopathy and bleeding disorder. 3. Pre-existing local infection at the site of saddle block. 4. Pregnant or lactating women. 5. Contraindications or allergy to ropivacaine and diclofenac. 6. Patients having hemodynamic instability. 7. Patients having sensory or motor problems in the lower limbs. 8. Patients having pain in any area other than surgery site.

Design outcomes

Primary

MeasureTime frame
To compare the discharge readiness between 1 and 2 minutes of sitting after saddle block with hyperbaric ropivacaine in patients undergoing Fistula-in-Ano surgeryTimepoint: 0 min, 5 min, 10 min, 15 min, 30 min, 60 min, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

Secondary

MeasureTime frame
1. To assess any complications like hypotension, urinary retention, postoperative nausea/vomiting, headache and backache. 2. To assess visual analogue scale (VAS) at rest and on movement. 3. To calculate mean analgesic consumption of diclofenac up to 24 hours. 4. To evaluate surgeon satisfaction score.Timepoint: 0 min, 5 min, 10 min, 15 min, 30 min, 60 min, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

Countries

India

Contacts

Public ContactDr Deepak Thapa

Government Medical College and Hospital, Sector 32, Chandigarh

dpkthapa@gmail.com9646121524

Outcome results

None listed

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