A CLINICAL TRIAL TO COMPARATIVELY STUDY HYPERBARIC ROPIVACAINE 0.75% AND HYPERBARIC BUPIVACAINE 0.5% FOR SPINAL ANAESTHESIA
- Conditions
- Health Condition 1: S00-T88- Injury, poisoning and certain other consequences of external causes
- Registration Number
- CTRI/2022/12/048607
- Lead Sponsor
- Dayanand Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
1.Patients aged between 18-65 years of either gender scheduled for lower limb surgery under spinal anaesthesia.
2.American Society of Anaesthesiologists (ASA) grade I, II and III.
1.Patient refusal for subarachnoid block.
2.Allergy to local anaesthetic drugs or any history of anaphylactic reaction to the drugs used.
3.Frank coagulopathy evidenced by history and laboratory investigations.
4.Infection at injection site.
5.Patients with spinal deformities like kyphoscoliosis and scoliosis etc.
6.Patients with history of pre-existing neurological disease.
7.Unable to comprehend sensory and motor block.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of sensory block (minutes) measured as the period from intrathecal injection till two dermatome regression.Timepoint: Every 2 minutes for the first 10 minutes and then every 15 minutes till two segment regression
- Secondary Outcome Measures
Name Time Method 1.The onset of sensory block (minutes) - The onset of sensory block will be defined as the time between injection of intrathecal anaesthetic and the absence of pain at T10 dermatome assessed by pinprick testTimepoint: Time to onset of sensory block;2.Maximum level of sensory blockTimepoint: Time to maximum sensory level;3.Time required to achieve maximum level of sensory block (minutes)Timepoint: Time to maximum sensory level;4.Time required for onset of motor block (minutes) - Time for onset of motor block will be defined as the period from intrathecal injection till the MBS is grade 3.Timepoint: Time to onset of motor block;5.Total duration of motor block (minutes) – It is defined as the period from intrathecal injection till complete motor block recovery (MBS- grade 0).Timepoint: Total duration of motor block