A Clinical study to compare the effect and safety of Ropivacaine Hydrochloride in dextrose and Bupivacaine Hydrochloride in dextrose injection in lower limb orthopaedic surgeries under spinal anaesthesia.
- Conditions
- Health Condition 1: 3- Administration
- Registration Number
- CTRI/2020/02/023372
- Lead Sponsor
- eon Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 217
To be eligible for the study, Subjects must meet all the following criteria:
1.Male and female subjects of age between 18 to 65 years (both inclusive).
2.Subjects belonging to ASA Grade I to II.
3.Subjects undergoing lower limb orthopaedic surgeries of duration <3 hours under spinal anaesthesia.
4.Subjects willing to sign informed consent for participation in the study.
Subjects will be excluded from the study for any of the following reasons:
1.Subjects with known hypersensitivity to the investigational medicinal products.
2.Subjects with contraindications for spinal anaesthesia.
3.Subjects receiving treatment with MAO inhibitors, Phenothiazines and Tricyclic antidepressants within 14 days prior to participation in the trial.
4.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
5.Subjects with suspected inability to comply with the study procedure.
6.Female subjects who are pregnant or lactating.
7.Female subjects who are not ready to use acceptable contraceptive methods during the course of study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in <br/ ><br>1. Time required to reach sensory block up to T10. <br/ ><br>2. Peak level of sensory block. <br/ ><br>3. Time taken for two segment regression from peak level of sensory block. <br/ ><br>4.Total duration of sensory block from time of injection to first demand for analgesia. <br/ ><br>5. Time required for onset and complete recovery of motor block as measured by modified Bromage scale. <br/ ><br>6. Time required for first micturition,achieve independent mobility. <br/ ><br>Timepoint: 48±6 Hours
- Secondary Outcome Measures
Name Time Method 1. Mean change in vital parameters (Heart Rate, BP, Respiratory rate& SPO2). <br/ ><br>2.The assessment of safety will be based on the frequency of adverse events and change in laboratory values. <br/ ><br>Timepoint: 48±6 Hours