Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Study Overview
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Brief Summary
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the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia

Detailed Description
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The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.

Official Title
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Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Bupivacaine, fentanyl
* Drug: Bupivacaine, dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancy Singleton ASA I and II, BMI <35, elective C/section Exclusion Criteria: patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomize controlled trial (RCT)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group BF<br>hyperbaric Bupivacaine 10mg with fentanyl 10micrograms | Drug: Bupivacaine, fentanyl<br>* Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,<br>|
| Experimental: Group BD<br>hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms | Drug: Bupivacaine, dexmedetomidine<br>* Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time till T10 dermatome achieved (Sec) | Spinal block characteristics | Post operative initial hour | 
| Time of maximum bromage achieved (Sec) | Spinal block characteristics | Post operative initial hour | 
| Regression time to T10 dermatome (Min) | Spinal block characteristics | Post operative initial hour | 
| Time of complete motor recovery (Min) | Spinal block characteristics | Post operative initial hour | 
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 1 hour | 
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 2 hour | 
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 3 hour | 
| Post-operative pain score | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down | 4 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | Sensation to throw out stomach contents | 24 hours Post operative | 
| Vomiting | Act of throwing out stomach contents through mouth | 24 hours Post operative | 
| Pruritus | Unpleasing sensation on the skin that provokes to scratch | 24 hours Post operative | 
| Respiratory distress | Difficulty in breathing | 24 hours Post operative | 
| Shivering | The act of shaking slightly and uncomfortably due to felling of cold temperature | 24 hours Post operative | 
| Bradycardia | Heat rate less than <60 bpm | 24 hours Post operative | 
| Hypotension | Decrease in BP greater than 20% of baseline | 24 hours Post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective low segment caesarean section, Intrathecal, bupivacaine-fentanyl, bupivacaine-dexmedetomidine, sensory block, complications, hemodynamics