Dexmedetomidine for Bilateral Superficial Cervical Plexus Block for Reconstructive Tracheal Surgery

Study Overview
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Brief Summary
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Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated. Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies. Levobupivacaine, is S-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

Detailed Description
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The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper tracheal resection and reconstruction surgery.

Official Title
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Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia

Conditions
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Tracheal Reconstruction

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Levobupivacaine-Dexmedetomidine
* Other: General Anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status I or II. Exclusion Criteria: History of allergy to the drugs used Coagulation disorders Pregnancy Postpartum period. Lactating females Local sepsis

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

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Levobupivacaine<br>Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia | Drug: Levobupivacaine<br>* Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine<br>Other: General Anaesthesia<br>* Using propofol, fentanyl and atracurium<br>|
| Active Comparator: Levobupivacaine-Dexmedetomidine<br>Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia | Drug: Levobupivacaine-Dexmedetomidine<br>* Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine<br>Other: General Anaesthesia<br>* Using propofol, fentanyl and atracurium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative postoperative opioid consumption | Total postoperative opioid consumption | For 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Perioperative changes in systolic blood pressure | Before and for 6 hours after start of anaesthesia | 
| Diastolic blood pressure | Perioperative changes in diastolic blood pressure | Before and for 6 hours after start of anaesthesia | 
| Heart rate | Perioperative changes in heart rate | Before and for 6 hours after start of anaesthesia | 
| Peripheral oxygen saturation | Perioperative changes in peripheral oxygen saturation | Before and for 6 hours after start of anaesthesia | 
| End-tidal carbon dioxide tension | Perioperative changes in end-tidal carbon dioxide tension | Before and for 6 hours after start of anaesthesia | 
| Time for first analgesic request of analgesia following extubation | Time to receiving the rescue analgesic following surgery | For 24 hours after surgery | 
| Pain scores | Using visual analogue score (it is 100 mm unmarked line in which 0 = no pain and 100 = worst pain),score >30 mm needs rescue analgesics | For 24 hours after surgery | 
| Cortisol serum level | Perioperative changes in cortisol level | before induction of anaesthesia , one hour after the block then one hour after recovery |