Local Wound Infiltration for Tracheal Reconstruction

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 postintubation 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 Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach. 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 local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.

Official Title
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Local Wound Infiltration Versus Bilateral Superficial Cervical Plexus Block With Levobupivacaine for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia.

Conditions
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Upper Tracheal Resection, Tracheal Reconstruction Surgery

Intervention / Treatment
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* Procedure: Superficial cervical plexus block
* Procedure: Local wound infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical class status I or II Undergoing elective upper tracheal resection and reconstruction surgery Exclusion Criteria: Age less than18 years Patients with preoperative medication included opioid History of allergy to the drugs used Coagulation disorders Pregnancy Patient refusal Local sepsis Inability to understand the study protocol or pain scale.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superficial cervical plexus block<br>Patients will receive bilateral superficial cervical plexus block using levobupivacaine | Procedure: Superficial cervical plexus block<br>* Patients will receive bilateral superficial cervical plexus block<br>|
| Active Comparator: Local wound infiltration<br>Patients will receive local wound infiltration with levobupivacaine after the conclusion of surgery | Procedure: Local wound infiltration<br>* Patients will receive local wound infiltration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score | Postoperative pain scores will be assessed using postoperative visual analogue score | For 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure |  | For 4 hours after start of surgery | 
| Diastolic blood pressure |  | For 4 hours after start of surgery | 
| Heart rate |  | For 4 hours after start of surgery | 
| Peripheral oxygen saturation |  | For 4 hours after start of surgery | 
| End-tidal Carbon dioxide tension |  | For 4 hours after start of surgery | 
| Bispectral index |  | For 4 hours after start of surgery | 
| Duration of analgesia | It is defined as time taken for first analgesic request of analgesia from extubation | For 24 hours after surgery | 
| Cumulative analgesic consumption | total analgesics used for 24 hrs after surgery | For 24 hours after surgery | 
| Cortisol serum | Plasma cortisol assay | before induction ,one hour after start of surgery and one hour after end of surgery |