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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05145543
Enrollment
80
Registered
2021-12-06
Start date
2021-12-01
Completion date
2022-03-31
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Sinus Surgery, Fentanyl

Keywords

dexamethasone, Levobupivacaine

Brief 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

Interventions

DRUGSaline 0.9%

0.9 NaCl % (Saline) (5 ml) will be applied

0.25 % levobupivacaine (5 ml) will be applied.

DRUGFentanyl

fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.

DRUGDexamethasone

Dexamethasone plus levobupivacaine (5 ml) will be applied.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
time to first post-operative analgesic request24 hours postoperativewhen patient require analgesia

Countries

Egypt

Contacts

Primary ContactGhada Abo Elfadl, MD
ghadafadl77@gmail.com01005802086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026