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Effects of adding fentanyl versus tramadol with hyperbaric bupivacaine for spinal anaesthesia in urological surgeries.

A comparative study to assess the effects of intrathecal fentanyl and intrathecal tramadol combined with 0.5% bupivacaine heavy in patients undergoing elective urological surgeries: A prospective randomized study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054882
Enrollment
60
Registered
2023-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: N400- Benign prostatic hyperplasia without lower urinary tract symptoms Health Condition 3: N329- Bladder disorder, unspecified Health Condition 4: N202- Calculus of kidney with calculus of ureter Health Condition 5: N219- Calculus of lower urinary tract, unspecified Health Condition 6: N201- Calculus of ureter Health Condition 7: N00-N99- Diseases of the genitourinary system Health Condit

Interventions

Intervention1: Hyperbaric Bupivacaine with Fentanyl: 2.5 ml of 0.5% bupivacaine heavy with 0.5 ml of fentanyl (25 µg) intrathecally during induction of spinal anaesthesia Control Intervention1: Hyper

Sponsors

Dr Baig Mirza Wajeed
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient giving consent to participate in study and scheduled for elective urosurgery. Age between 20-60 years ASA grade I and II

Exclusion criteria

Exclusion criteria: Patients not giving consent to participate in the study. ASA grade III and IV Patients with respiratory, cardiovascular, hepatic and renal diseases, obesity and pregnancy. Age below <20 years and above >60 years. Any bleeding disorder and patient on anticoagulants. Neurological and musculoskeletal disease. Local infection at the injection site. Patient already receiving any analgesic. Patient already receiving opioid agonist or antagonist in preceding 6 hrs of surgery

Design outcomes

Primary

MeasureTime frame
Prolonged duration of analgesia with the addition of intrathecal fentanyl. Stable haemodynamic profile with intrathecal tramadol.Timepoint: from induction of spinal anaesthesia to 6 hrs postoperative period

Secondary

MeasureTime frame
Lesser side effects with intrathecal tramadol.Timepoint: from induction of spinal anaesthesia to 6 hrs postoperative period

Countries

India

Contacts

Public ContactDr Manmohan Jindal

Gajra Raja Medical college, Gwalior

drmmjindal@gmail.com9785728405

Outcome results

None listed

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