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To compare the effect of the drug named Fentanyl in Spinal anaesthesia in Orthopedic surgery patients.

â??EVALUATION OF SAFETY AND EFFICACY OF HYPERBARIC BUPIVACAINE (0.5%) VERSUS HYPERBARIC BUPIVACAINE (0.5%) WITH 25 μg FENTANYL IN SUBARACHNOID BLOCK IN PARTICIPANTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERY: A PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL TRIALâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006956
Enrollment
100
Registered
2016-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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: null- participants belonging to ASA grade I and II scheduled to undergo lower limb orthopaedic surgery .

Interventions

Intervention1: Inj. Fentanyl: Injection Bupivacaine hyperbaric 0.5% 3.0 cc (15mg) + Injection Fentanyl 0.5 cc (25 microgram) given in subarachnoid space. Control Intervention1: Normal saline: Injectio

Sponsors

Govt Medical college Bhavnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II, Paricipants undergoing lower limb orthopaedic surgery under subarachnoid block, Informed written consent for participation in study

Exclusion criteria

Exclusion criteria: 1.Partticipants having contraindications to subarachnoid block (congrnital spinal anomalies, altered coagulation profile, local site skin infection) 2.Participants having severe psychiatric disorders (depression, dementia) 3.Participants having neurological diseases (brain tumor, CNS syphilis, meningitis) 4.Spinal cord and peripheral nerve diseases, poliomyelitis, multiple sclerosis 5.Participants having allergy to local anesthetic drug 6.drug/alcohol abuse 7.Participants not willing for subarachnoid block 8.Any pregnant lady

Design outcomes

Primary

MeasureTime frame
1. Sensory characteristics of block Onset,Peak,Duration 2. Motor characteristics of block Onset,Peak,Duration 3. Post operative analgesia a) Duration of post-operative analgesia. b) Total dose and frequency of rescue analgesics required in 24 hours Timepoint: 1. Sensory characteristics of block Onset,Peak,Duration 2. Motor characteristics of block Onset,Peak,Duration 3. Post operative analgesia a) Duration of post-operative analgesia. b) Total dose and frequency of rescue analgesics required in 24 hours—

Secondary

MeasureTime frame
1. Effect on hemodynamic variables like pulse, mean arterial pressure,oxygen saturation. 2. Complications of drug and technique, if any (for e.g. nausea, vomiting, bradycardia, hypotension, pruritis, shivering, anaphylaxis,respiratory depression) Timepoint: Intra-op pulse,BP and oxygen saturation monitoring throughout the surgery. After the completion of surgery,sensory and motor block assessment 30 min interval till regression of sensory and motor blockade,4 hourly interval for next 24 hours for complications and adverse events if any. Time of analgesia request(TAR) noted in post-op period,pain intensity assessed by a Visual Analogue Scale (VAS) graded 1-10 cm.—

Countries

India

Contacts

Public ContactDr Shilpa Doshi

Govt. Medical College, Bhavnagar.

drshilpadoshi@yahoo.in9428810763

Outcome results

None listed

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