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

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04410588
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13.4
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

the Investigators aim to study the effect of fentanyl with topical levobupivacaine with nasal packing in endoscopic nasal surgery

Condition or Disease	Intervention/Treatment	Phase
Analgesia During Removal of Nasal Pack After Nasal Surgery	Drug: Fentanyl + Topical Levobupivacaine; Drug: levobupivacaine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Fentanyl With Topical Levobupivacaine With Nasal Packing in Endoscopic Nasal Surgery
• Actual Study Start Date: Jun 20, 2020
• Actual Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. postoperative pain by visual analoge score [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wael	Assiut	Asyut	Egypt	11711

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa mahmoud Abd El Rady, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04410588
• Other Study ID Numbers: marwawael
• First Posted: Jun 1, 2020
• Last Update Posted: Aug 20, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fentanyl; Levobupivacaine

Study Results

No Results Posted as of Aug 20, 2021