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

Fentanyl Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145543
• Other study ID #: 17300428
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2021
• Est. completion date: March 2022

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: Ghada Abo Elfadl, MD
• Phone: 01005802086
• Email: ghadafadl77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Endoscopic Sinus Surgery
• Fentanyl

Intervention

Drug:
• Saline 0.9%
0.9 NaCl % (Saline) (5 ml) will be applied
• Levobupivacaine Hydrochloride
0.25 % levobupivacaine (5 ml) will be applied.
• Fentanyl
fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
• Dexamethasone
Dexamethasone plus levobupivacaine (5 ml) will be applied.

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chaaban MR, Rana N, Baillargeon J, Baillargeon G, Resto V, Kuo YF. Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2018 Sep;32(5):388-396. doi: 10.1177/1945892418782248. Epub 2018 Jun 27. — View Citation

Krings JG, Kallogjeri D, Wineland A, Nepple KG, Piccirillo JF, Getz AE. Complications of primary and revision functional endoscopic sinus surgery for chronic rhinosinusitis. Laryngoscope. 2014 Apr;124(4):838-45. doi: 10.1002/lary.24401. Epub 2013 Oct 9. — View Citation

Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first post-operative analgesic request	when patient require analgesia	24 hours postoperative