NCT05145543

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Endoscopic Sinus Surgery
• Fentanyl

Interventions

Type	Name	Description
DRUG	Saline 0.9%	0.9 NaCl % (Saline) (5 ml) will be applied
DRUG	Levobupivacaine Hydrochloride	0.25 % levobupivacaine (5 ml) will be applied.
DRUG	Fentanyl	fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
DRUG	Dexamethasone	Dexamethasone plus levobupivacaine (5 ml) will be applied.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-12-06
• Last updated: 2021-12-06

Locations

1 site across 1 country: Egypt