To compare the effect of the drug named Fentanyl in Spinal anaesthesia in Orthopedic surgery patients.
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: null- participants belonging to ASA grade I and II scheduled to undergo lower limb orthopaedic surgery .
- Registration Number
- CTRI/2016/05/006956
- Lead Sponsor
- Govt Medical college Bhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Sensory characteristics of block <br/ ><br>Onset,Peak,Duration <br/ ><br>2. Motor characteristics of block <br/ ><br>Onset,Peak,Duration <br/ ><br>3. Post operative analgesia <br/ ><br>a) Duration of post-operative analgesia. <br/ ><br>b) Total dose and frequency of rescue analgesics required in 24 hours <br/ ><br>Timepoint: 1. Sensory characteristics of block <br/ ><br>Onset,Peak,Duration <br/ ><br>2. Motor characteristics of block <br/ ><br>Onset,Peak,Duration <br/ ><br>3. Post operative analgesia <br/ ><br>a) Duration of post-operative analgesia. <br/ ><br>b) Total dose and frequency of rescue analgesics required in 24 hours <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Effect on hemodynamic variables like pulse, mean arterial pressure,oxygen saturation. <br/ ><br>2. Complications of drug and technique, if any (for e.g. nausea, vomiting, <br/ ><br> bradycardia, hypotension, pruritis, shivering, anaphylaxis,respiratory depression) <br/ ><br>Timepoint: Intra-op pulse,BP and oxygen saturation monitoring throughout the surgery. <br/ ><br>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. <br/ ><br>Time of analgesia request(TAR) noted in post-op period,pain intensity assessed by a Visual Analogue Scale (VAS) graded 1-10 cm.