Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

Study Overview
=================
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

Official Title
-----------------
Comparison of the Effect of Adding Midazolam Versus Fentanyl to Intrathecal Levobupivacaine in Patients Undergoing Caesarean Section

Conditions
-----------------
Cesarean Section Complications

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of American Society of Anaesthesiologists grades I and II , Exclusion Criteria: pre-existing neurological or spinal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group M<br>. Group M (n = 40) receive 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg) ) intrathecally | Drug: Midazolam<br>* 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg)will be given intrathecally 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<br>|
| Experimental: group F<br>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 | Drug: Fentanyl<br>* 2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg)will be given intrathecally 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st post-operative analgesic request | 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. | 24-hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of sensory block Total analgesic consumption | total duration of sensory block (regression to S1 dermatome) will be noted | 24-hour |