Dexamethasone & Bupivacaine vs Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Perioperative Analgesia in Patients Undergoing Lower Limb Surgeries

Study Overview
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Brief Summary
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In regional anesthesia local anaesthetics alone provide analgesia for not more than 4-8 hours. Increasing the duration of local anaesthetic action is often desirable because it prolongs surgical anaesthesia and analgesia. Different additives have been used to prolong regional blockade. Vasoconstrictors can be used to constrict vessels, thereby reducing vascular absorption of the local anaesthetic. Additives like opioids, clonidine and verapamil were added to local anaesthetics, but the results are either inconclusive or associated with side effects. Steroids when used intrathecally are reported to cause arachnoiditis, but there is no evidence suggesting any neuritis when steroids are used in low concentration in peripheral nerve blocks. Steroids have powerful anti-inflammatory as well as analgesic properties. Perineural injection of steroids is reported to influence postoperative analgesia. They relieve pain by reducing inflammation, and blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge. The addition of 5 mg of dexamethasone to 10 ml of 0.5% levobupivacaine in interscalene brachial plexus block showed improvement of postoperative analgesia for arthroscopic shoulder operation without any specific complications. The objective of this study is to compare the effects of combining of dexamethasone and bupivacaine versus bupivacaine alone in combined femoral and sciatic nerve block in patients undergoing lower limb vascular surgeries. The effects will be studied in terms of: Onset of sensory blockade and motor blockade Duration of analgesia / first request for analgesic Duration of motor blockade

Official Title
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Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries

Conditions
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Pain

Intervention / Treatment
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* Drug: Perineural Dexamethasone and bupivacaine
* Drug: Systemic Dexamethasone plus perineural bupivacaine
* Drug: intravenous saline plus perineural bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ranging from 18 to 70 years American Society of Anesthesiologists (ASA) physical status I, II and III Patients scheduled for lower limb vascular surgeries Exclusion Criteria: Patient refusal for the procedure Any bleeding disorder or patients on anticoagulant therapy Neurological deficits involving lumbar or sacral plexuses Patients with allergy to local anaesthetics Local infection at the injection site Patients on any sedative or antipsychotic drugs Body mass index > 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: perineural dexamethasone group<br>21 patients received perineural dexamethasone plus bupivacaine 0.5% | Drug: Perineural Dexamethasone and bupivacaine<br> <br> |
| Active Comparator: systemic dexamethasone group<br>21 patients received systemic (intravenous) dexamethasone plus perineural bupivacaine 0.5% | Drug: Systemic Dexamethasone plus perineural bupivacaine<br> <br> |
| Sham Comparator: control group<br>21 patients received only perineural bupivacaine 0.5% plus intravenous saline | Drug: intravenous saline plus perineural bupivacaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of onset of sensory blockade | from time of performing the nerve block till the occurrence of sensory block | upto 30 min | 
| Time of onset of motor blockade | from time of performing the nerve block till the occurrence of motor block | up to 30 min | 
| Duration of analgesia | time from onset of analgesia till the first request for an analgesic | upto 24 hours | 
| Duration of motor blockade | time from motor blockade till ability to move the limb | upto 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative hemodynamics | systolic and diastolic blood pressure, heart rate before starting the procedure;Respiratory rate;and Oxygen saturation during the procedure and in the 24 hours following the procedure | time immediately before block and every 30 minutes till end of surgery and 24 hours after surgery (1 hour interval) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia, dexamethasone, bupivacaine, femoral, sciatic