Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section
- Registration Number
- NCT03824314
- Lead Sponsor
- Mohamed Abdelrady Mohamed
- Brief Summary
The aim of this study is to compare the effects of intrathecal levobupivacaine plus midazolam and levobupivacaine plus fentanyl in patients undergoing caesarean section to get a prolonged postoperative analgesic effect and less side effects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
- Patients of American Society of Anaesthesiologists grades I and II ,
Exclusion Criteria
- pre-existing neurological or spinal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group F Fentanyl group F (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg) intrathecally. Under all aseptic precautions, spinal anaesthesia will be given in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position Group M Midazolam . Group M (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg) ) intrathecally
- Primary Outcome Measures
Name Time Method 1st post-operative analgesic request 24-hour pain will be evaluated using VAS score, every 30 min for 180 min then hourly for 12 h and thereafter every 3 hourly till 24 h of surgery in both groups. Rescue analgesia in the form of injection Ketorolac 30mg I.V when VAS \>3 in both groups.
- Secondary Outcome Measures
Name Time Method duration of sensory block Total analgesic consumption 24-hour total duration of sensory block (regression to S1 dermatome) will be noted
Trial Locations
- Locations (1)
Mohamed
🇪🇬Assiut, Egypt