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To assess and compare the post-op analgesic effect of intrathecal Buprenorphine versus Fentanyl Citrate with control group, as an adjuvant to 0.5% hyperbaric Bupivacaine in lower abdominal surgeries.

Comparison of Post-Operative Analgesic Properties of Intrathecal Buprenorphine versus Fentanyl Citrate as an Adjuvant to 0.5% Hyperbaric Bupivacaine for Lower Abdominal Surgeries: A Randomized Double Blind Interventional Controlled Study at S.M.S. Medical College and Attached Group of Hospitals, Jaipur during 2020-2021.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030624
Enrollment
90
Registered
2021-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Interventions

Intervention1: Injection Buprenorphine 60 micrograms: Intrathecal administration of Injection Buprenorphine 60 mcg ( 0.5ml at 1:2.5 dilution) to 0.5% 15 mg Hyperbaric Bupivacaine (3ml) Intervention2:

Sponsors

Sawai Man Singh Medical College And Attached Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients Undergoing lower abdominal surgeries Patients with Body Weight: 45 to 70 kg Patients classified under American Society of Anesthesiologists as: Grade I: Without Co- morbid Conditions Grade II: Controlled Co- morbid Conditions

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in the study. 2. Cases with sepsis, bacteremia or skin infection of local site 3. History of severe hypovolemia, anemia and compromised renal, cardiac or respiratory status 4. Cases with raised intracranial tension 5. History of blood coagulopathies 6. Patient allergic to drugs used for study 7. Uncooperative patients 8. Failure of spinal anesthesia, cases in which general anaesthesia will be required.

Design outcomes

Primary

MeasureTime frame
To determine the difference in mean time duration for the need of first rescue analgesia.Timepoint: 24 hours.—

Secondary

MeasureTime frame
1.To assess and compare the onset time and duration of Sensory and Motor block. 2.To assess and compare Hemodynamic parameters: (Heart Rate; Mean Blood Pressure; Systolic Blood Pressure; Diastolic Blood Pressure), Sedation score and VAS score. 3.To find out and compare the proportion of cases with complications. Timepoint: 24 hours.—

Countries

India

Contacts

Public ContactDrGajendra Sharma

SMS Medical college ,Jaipur

bafnausha@yahoo.com9413901579

Outcome results

None listed

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