Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery (fentanyl)

August 16, 2021 updated by: Marwa mahmoud Abd El Rady, Assiut University
the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: wesam A Nashat

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:1. All patients in the age of 18-60 year 2. ASA I-II 3. Undergoing elective nasal endoscopic surgery

-

Exclusion Criteria:

  1. Patients will also be excluded if any perioperative cardiovascular or respiratory event occurred which the anaesthetist with clinical responsibility for the patient thought would make the study intervention clinically unacceptable.
  2. unsatisfactory preoperative peripheral arterial oxygen saturation.
  3. Unsatisfactory preoperative hemoglobin level.
  4. Neurological or psychiatric disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: saline
saline for pain for nasal packing
ACTIVE_COMPARATOR: levobupivacaine
levobupivacaine for pain of nasal packing
Drug: levobupivacaine
in nasal packing
ACTIVE_COMPARATOR: fentanyl +levobupivacaine
fentanyle with levobupivacaine for pain of nasal packing
Drug: Fentanyl + Topical Levobupivacaine
in nasal packing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain by visual analoge score
Time Frame: 24 houres postoperative pain assessment
assessment of pain on removal of nasal packing after endoscopic nasal surgery by VAS score. The Visual Analogue Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain)
24 houres postoperative pain assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2020

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ANTICIPATED)

August 1, 2021

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (ACTUAL)

June 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • marwawael

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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