Comparing two different doses of bupivacaine in epidural volume extension
- Conditions
- male patients undergoing Orthopedic lower limb surgery
- Registration Number
- CTRI/2016/12/007606
- Lead Sponsor
- University College of Medical Sciences and Guru Teg Bahadur Hospital
- Brief Summary
This trial is a comparison of two diffrent doses of plain bupivacaine (5m and 8mg) for epidural volume extension induced sensory block augumentation. It aiims to evaluate whether the intrathecal dose affects the efficacy of epidural volume extension. We will determine and compare, in patients undergoing orthopaedic surgery for lower limb,the maximum sensory block level achieved with or without epidural volume extension, following intrathecal injection of 5 mg Plain bupivacaine (along with 25μg fentanyl). The same will be done for 8mg of intrathecal plain bupivacaine. Combined spinal epidural anesthesia will be performed according to standrad practice. Epidural volume extension will be performed by injecting 10ml normal saline in epidural space
The comparison of Smax with or without epidural volume extension following either intrathecal dose i.e., between groups PE5 and PNE5; and between PE8 and PNE8; as well as that of ∆Smax with either dose of intrathecal bupivacaine; will be done using Mann Whitney-U test. For other comparisons, appropriate statistical tests will be applied as required. A p-value <0.05 will be considered statistically significant.
Sample size was determined using two-sided, two-sample t-test for comparing means at a power of 80% and α error of 5%. Taking previously reported standard deviation of 1 dermatome in the maximum sensory block level after 5 mg and 8 mg intrathecal plain bupivacaine in patients undergoing lower limb surgery, 17 patient would be required in each group to detect a difference of 1 dermatome following epidural volume extension. Adding another 10% for possible withdrawals due to various reasons such as failure of block, and 15% for the maximum sensory level being non-parametric in distribution, at least 21 patients would be required in each group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 84
ASA status I or II with body weight between 50-70 kg and height of 150-180 cm undergoing lower limb surgery using combined spinal epidural technique.
Patients with diabetes mellitus, history of spinal disease or coagulation abnormalities, skin infection at site of injection and other contraindications to combined spinal epidural anesthesia including hypersensitivity to local anesthetics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The maximum sensory block level (Smax) achieved The sensory blockade will be assessed every 3 min till there is no further increase in 3 consecutive readings. This level of sensory blockade will be designated as maximum level of sensory block (Smax).
- Secondary Outcome Measures
Name Time Method The increase in maximum sensory block level caused by epidural volume extension The sensory blockade will be assessed every 3 min till there is no further increase in 3 consecutive readings. This level of sensory blockade will be designated as maximum level of sensory block (Smax).
Trial Locations
- Locations (1)
University College of Medical Sciences and Guru Teg Bahadur Hospital
🇮🇳East, DELHI, India
University College of Medical Sciences and Guru Teg Bahadur Hospital🇮🇳East, DELHI, IndiaDr Asha TyagiPrincipal investigator9868333713drashatyagi@gmail.com