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

NCT ID: NCT05145543

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-03-31

Brief Summary

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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

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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

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Endoscopic Sinus Surgery Fentanyl

Keywords

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dexamethasone Levobupivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group C

0.9 NaCl % (Saline) (5 ml)

Group Type PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type DRUG

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

Group L

0.25 % levobupivacaine (5 ml) will be applied.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride

Intervention Type DRUG

0.25 % levobupivacaine (5 ml) will be applied.

Group LF

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

Group Type EXPERIMENTAL

Levobupivacaine Hydrochloride

Intervention Type DRUG

0.25 % levobupivacaine (5 ml) will be applied.

Fentanyl

Intervention Type DRUG

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

Group LD

dexamethasone plus levobupivacaine (5 ml) will be applied.

Group Type EXPERIMENTAL

Levobupivacaine Hydrochloride

Intervention Type DRUG

0.25 % levobupivacaine (5 ml) will be applied.

Dexamethasone

Intervention Type DRUG

Dexamethasone plus levobupivacaine (5 ml) will be applied.

Interventions

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Saline 0.9%

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

Intervention Type DRUG

Levobupivacaine Hydrochloride

0.25 % levobupivacaine (5 ml) will be applied.

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Dexamethasone

Dexamethasone plus levobupivacaine (5 ml) will be applied.

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ghada Abo Elfadl, MD

Role: CONTACT

Phone: 01005802086

Email: [email protected]

Facility Contacts

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Ghada M Aboelfadl, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 24122737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29947260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22086769 (View on PubMed)

Other Identifiers

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17300428

Identifier Type: -

Identifier Source: org_study_id