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

Phase 2

• Conditions: Endoscopic Sinus Surgery; Fentanyl
• Interventions: Drug: Levobupivacaine Hydrochloride; Drug: Saline 0.9%; Drug: Fentanyl; Drug: Dexamethasone

• Registration Number: NCT05145543
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-26
• Study Start: 2021-12-01
• Study First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-03
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Levobupivacaine Hydrochloride	0.25 % levobupivacaine (5 ml) will be applied.
Group LF	Levobupivacaine Hydrochloride	fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
Group LD	Levobupivacaine Hydrochloride	dexamethasone plus levobupivacaine (5 ml) will be applied.
Group C	Saline 0.9%	0.9 NaCl % (Saline) (5 ml)
Group LF	Fentanyl	fentanyl plus 0.25 % levobupivacaine (5 ml) will be applied.
Group LD	Dexamethasone	dexamethasone plus levobupivacaine (5 ml) will be applied.

Primary Outcome Measures

Name	Time	Method
time to first post-operative analgesic request	24 hours postoperative	when patient require analgesia

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt