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Comparing two drugs namely Fentanyl and Buprenorphine by adding to 0.5% Hyperbaric Bupivacaine a spinal anaesthesia drug used for lower abdominal surgeries: A Randomised Clinical Trial

A comparative study of the effect of intrathecal Fentanyl and Buprenorphine as an adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under spinal anaesthesia: A Randomised Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108965
Enrollment
120
Registered
2026-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: K352- Acute appendicitis with generalized peritonitis Health Condition 2: N700- Acute salpingitis and oophoritis Health Condition 3: N400- Benign prostatic hyperplasia without lower urinary tract symptoms Health Condition 4: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 5: N200- Calculus of kidney Health Condition 6: N201- Calculus of ureter Health Condition 7: N711- Chronic inflammatory disease of uterus Health Condition 8: K650- Generalize

Interventions

Intervention1: Buprenorphine: Drug Intervention2: Hyperbaric Bupivacaine Heavy: Drug for Spinal Anaesthesia in the dose of 12.5 milligram which is 2.5 millilitre in the form of 0.5 percent Hyperbaric

Sponsors

Regional Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 60 years of either sex undergoing spinal anaesthesia for elective infraumbilical surgeries, such as surgical procedures on lower abdomen, genitourinary region including gynaecological and urological surgeries 2. Patients of American Society of Anaesthesiologists (ASA) grade 1 or 2 3. Either sex

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation 2. Uncooperative patient and patient refusal to give consent 3. Patient with history of allergy to the drugs(hyperbaric Bupivacaine, Fentanyl, Buprenorphine) 4. Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled thyroid disorder, height more than 180 cm or height less than 140 cm and weight more than 110 kgs or weight less than 45 kgs 5. Patients with cardiovascular, respiratory, renal, hepatic or neurological disease 6. Patients contraindicated for spinal anesthesia such as local site infection, spinal deformity, patient with bleeding disorder-platelet count more than 50000/microliter, prothrombin time ore than 14 seconds, INR more than 1.5

Design outcomes

Primary

MeasureTime frame
To compare the duration of analgesia between the study groupsTimepoint: After the intrathecal injection, parameters as per the protocol will be recorded every 2 minutes for the first 10 minutes and every 5 minutes till 30 minutes and every 10 minutes till 60 minutes and every 30 minutes till 180 minutes

Secondary

MeasureTime frame
1. To compare the onset time of sensory & motor block between the the two groups 2. To assess the duration of sensory & motor block achieved with each adjuvant 3. To assess the hemodynamic stability 4. To identify the adverse effectsTimepoint: After the intrathecal injection every parameters as per the protocol will be recorded every 2 minutes for the first 10 minutes & every 5 minutes till 30 minutes & every 10 minutes till 60 minutes & every 30 minutes till 180 minutes

Countries

India

Contacts

Public ContactMaharambam Binarani

Regional Institute of Medical Sciences

shama.takhell@gmail.com8310675558

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026