Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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Chronic sinusitis (CRS) is a high incidence disease characterized by pus, nasal obstruction, olfactory disturbance, headache, and other symptoms, lasting for more than 12 weeks, with severe cases having ocular compression and visual impairment, which can cause cranial, eye, and lung complications. Chronic sinusitis is a high-risk disease.

Detailed Description
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One of the main concerns about using packing is that the removal is usually very painful and can be very bothersome. This procedure may even result in syncope by the activation of the vasovagal reflex system. There have been a few studies suggesting that nasal packs should not be used because removal from the nose causes serious discomfort and is painful. Many patients who have undergone nasal surgery report that the removal of the pack was the most painful part of the experience. Postoperative pain is an acute inflammatory pain that starts with surgical trauma and ends with tissue healing. It can be harmful to organ systems by initiating inflamma¬tion through different mechanisms, and the alleviation of postoperative pain is considered important for obtaining homeostasis. Pain may initiate atelectasis due to improper coughing, immobilization may cause thromboembolism and catecholamine discharge may induce cardiovascular side effects and undesired changes in neuroendocrine or meta¬bolic function

Official Title
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Effect of Topically Administered Levobupivacaine- Fentanyl Versus Levobupivacaine- Dexamethasone Combination in the Control of Pain After Endoscopic Sinus Surgery: A Randomized Controlled Trial

Conditions
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Endoscopic Sinus Surgery, Fentanyl

Intervention / Treatment
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* Drug: Saline 0.9%
* Drug: Levobupivacaine Hydrochloride
* Drug: Fentanyl
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • ASA physical status I-II patients scheduled for elective FESS surgery. • Age from 18 to 65 years patients Exclusion Criteria: • Age>18 and<65 years patients, Previous history of FESS, Patients with sensitivity to anesthetic agents in the study, Patients who will do additional septoplasty or turbinate surgery, Patients with disturbance of blood coagulation, including pro¬thrombin time (PT)/partial thromboplastin time (PTT) prolon¬gation, purpura, and spontaneous bleeding;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>0.9 NaCl % (Saline) (5 ml) | Drug: Saline 0.9%<br>* 0.9 NaCl % (Saline) (5 ml) will be applied<br>|
| Active Comparator: Group L<br>0.25 % levobupivacaine (5 ml) will be applied. | Drug: Levobupivacaine Hydrochloride<br>* 0.25 % levobupivacaine (5 ml) will be applied.<br>|
| Experimental: Group LF<br>fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied. | Drug: Levobupivacaine Hydrochloride<br>* 0.25 % levobupivacaine (5 ml) will be applied.<br>Drug: Fentanyl<br>* fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.<br>|
| Experimental: Group LD<br>dexamethasone plus levobupivacaine (5 ml) will be applied. | Drug: Levobupivacaine Hydrochloride<br>* 0.25 % levobupivacaine (5 ml) will be applied.<br>Drug: Dexamethasone<br>* Dexamethasone plus levobupivacaine (5 ml) will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first post-operative analgesic request | when patient require analgesia | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, Levobupivacaine