Evaluation of sensory and motor block characteristics of spinal anaesthesia in diabetic and non diabetic patients undergoing infra umbilical surgeries using 0.5 percent hyperbaric bupivacaine and 0.75 percent hyperbaric ropivacaine. A randomised controlled study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Maulana Azad Medical College
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- mean time to 2 segment regression of sensory block level
Study Overview
Brief Summary
This randomized controlled study aims to evaluate and compare the sensory and motor block characteristics of spinal anaesthesia in diabetic and non-diabetic patients undergoing infraumbilical surgeries using two local anaesthetics 0.5 percent hyperbaric bupivacaine and 0.75 percent hyperbaric ropivacaine. Diabetes mellitus is known to alter nerve conduction and sensitivity to local anaesthetics, potentially influencing block dynamics. The study will assess onset time, peak block level, and regression of both sensory and motor blocks, as well as the effect of CSF sugar and protein levels on these characteristics. A total of 56 patients will be randomized into four groups (diabetic/non-diabetic and bupivacaine/ropivacaine). The findings will help guide safer and more effective anaesthetic drug selection, particularly for diabetic patients, and support enhanced recovery practices in infra umbilical surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.height between 150-180cm 2.BMI between 19-30kg per meter square 3.ASA grade 1,2,3.
Exclusion Criteria
- •1.pregnancy 2.patients with known hypersensitivity to known drugs 3.patients with overt sensory sensory or motor deficit suggestive of diabetic neuropathy.
Outcomes
Primary Outcomes
mean time to 2 segment regression of sensory block level
Time Frame: every 15 minute after achieving maximum sensory block level
Secondary Outcomes
- mean time to achieve onset of sensory block (T10 dermatomal level)(every 1 minute for first 10 min , then every 2 minute for next 10 min)
- maximum sensory block achieved(every 1 minute for first 10 min then every 2 min for next 10 min)
- Mean time to achieve maximum sensory block level(Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes)
- Mean time to achieve onset of motor block ( modified bromage score 1)(Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes)
- Maximum motor block achieved(Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes)
- Mean time to achieve maximum motor block(Every 1 minute for first 10 minutes then every 2 min for the next 10 minutes)
- Mean time to achieve regression of motor block ( from maximum block to modified bromage score 1)(Every 15 minute after achieving maximum block level)
Investigators
Dr Prachi Gupta
Maulana Azad medical College