A Study Comparing Two Spinal Anesthesia Methods (Ropivacaine vs Bupivacaine with Fentanyl) in Patients Undergoing Lower Abdominal Surgery

COMPARATIVE STUDY OF INTRATHECAL ROPIVACAINE-FENTANYL VERSUS INTRATHECAL BUPIVACAINE-FENTANYL IN INFRAUMBILICAL SURGERIES. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088597

Enrollment

130

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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 Health Condition 2: K35-K38- Diseases of appendix Health Condition 3: K40- Inguinal hernia Health Condition 4: K41- Femoral hernia Health Condition 5: K60- Fissure and fistula of anal and rectal regions Health Condition 6: K61- Abscess of anal and rectal regions Health Condition 7: N20-N23- Urolithiasis Health Condition 8: N40-N53- Diseases of male genital organs Health Condition 9: N80-N98- Noninflammatory disorders of female genital tract Health Cond

Interventions

Intervention1: INTRATHECAL ROPIVACAINE-FENTANYL: The study population is divided into 2 group of 65 patients each Group RF used 15mg of 0.75% ropivacaine with 20 mcg of fentanyl Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient undergoing infraumbilical surgeries giving written informed consent for spinal anesthesia. 2.Age 18 to 60 years. 3.American Society of Anesthesiologists Grade I or II. 4.BMI 18.5-24.9kg/m2

Exclusion criteria

Exclusion criteria: 1.Patient with vertebral column disorder. 2.Patients with a history of respiratory, cardiac or hepatorenal disorder. 3.Patients with Clotting and Bleeding disorder 4.Patients with history of hypersensitivity to any of the drugs under study. 5.Pregnant patients 6.Patients with psychiatric disorders

Design outcomes

Primary

Measure	Time frame
a comparative study of intrathecal ropivacaine-fentanyl versus intrathecal bupivacaine-fentanyl in infraumbilical surgeries..Timepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes	—

Measure

Time frame

a comparative study of intrathecal ropivacaine-fentanyl versus intrathecal bupivacaine-fentanyl in infraumbilical surgeries..Timepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes

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Secondary

Measure	Time frame
1.To compare the duration of intraoperative & postoperative analgesia of intrathecal ropivacaine fentanyl versus bupivacaine fentanyl in infraumbilical surgeriesTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;2.To compare intra-operative & postoperative hemodynamic changes in both groupsTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;3.To compare intraoperative & postoperative adverse effect in both groupsTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;4.To compare intra operative & post operative VAS score & consumption of rescue analgesia in both groups Timepoint: at 0 minutes,20 minutes,40 minutes,60 minutes,80 minutes, 90 minutes	—

Measure

Time frame

1.To compare the duration of intraoperative & postoperative analgesia of intrathecal ropivacaine fentanyl versus bupivacaine fentanyl in infraumbilical surgeriesTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;2.To compare intra-operative & postoperative hemodynamic changes in both groupsTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;3.To compare intraoperative & postoperative adverse effect in both groupsTimepoint: at 0 minutes, 2 minutes, 4 minutes,6 minutes,8 minutes,10 minutes,12 minutes,14 minutes,16 minutes,18 minutes, 20 minutes, 25 minutes, 30 minutes,35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, 65 minutes, 70 minutes, 75 minutes, 80 minutes, 90 minutes;4.To compare intra operative & post operative VAS score & consumption of rescue analgesia in both groups Timepoint: at 0 minutes,20 minutes,40 minutes,60 minutes,80 minutes, 90 minutes

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Countries

India

Contacts

Public ContactDr Ajay kumar Sinha

Government medical college, Haldwani

drajayksinha@yahoo.co.in9897672301

Outcome results

None listed

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