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

Assiut University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Fentanyl; Endoscopic Sinus Surgery

Treatments: Drug: Dexamethasone; Drug: Saline 0.9%; Drug: Fentanyl; Drug: Levobupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05145543

17300428

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

0.9 NaCl % (Saline) (5 ml)

Treatment:

Drug: Saline 0.9%

Group L

Active Comparator group

Description:

0.25 % levobupivacaine (5 ml) will be applied.

Treatment:

Drug: Levobupivacaine Hydrochloride

Group LF

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Levobupivacaine Hydrochloride

Group LD

Experimental group

Description:

dexamethasone plus levobupivacaine (5 ml) will be applied.

Treatment:

Drug: Dexamethasone

Drug: Levobupivacaine Hydrochloride