Lidocaine in ERAS for FESS
Primary Purpose
Intraoperative Bleeding
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Intraoperative Bleeding
Eligibility Criteria
Inclusion Criteria:
- Patients, 20-50 yr ASA class I and II
- Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
Exclusion Criteria:
- Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index > 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
Sites / Locations
- Faculty of Medicine Assuit University
- Seham Mohamed Moeen Ibrahim
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine
Control
Arm Description
IV Lidocaine infusion
IV normal saline infusion
Outcomes
Primary Outcome Measures
Intraoperative bleeding
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
Secondary Outcome Measures
Quality of surgical field
The surgeon will assess the quality of surgical field every 15 min after the beginning of drug infusion for the first 60 min according to a 6-point Boezaart scale
Surgeon satisfaction
with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent
Mean arterial pressure
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Heart rate
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03047070
Brief Title
Lidocaine in ERAS for FESS
Official Title
Lidocaine Infusion in Functional Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Detailed Description
Functional endoscopic sinus surgery (FESS) is a commonly performed procedure in the head and neck field. It is known that bleeding during FESS can affect directly to the visibility of safe landmarks and surgical outcomes.
Use of vasoactive drugs to control bleeding is not without pitfalls. Systemic effects of epinephrine may constitute a potential hazard in patients with hypertension, ischemic heart disease, anemia, preexistent liver or renal damage and endocrine dysfunction (hyperthyroidism, pheochromocytoma and diabetes mellitus).
Lidocaine is a prototypical local anesthetic, but it also has systemic effects that are mediated by inhibitory effects on N-methyl-d-aspartate receptors and leukocyte priming. Consequently, systemic lidocaine is antiinflammatory, analgesic, and antihyperalgesic. Randomized clinical trials, however, have produced mixed results. Several studies have shown reduction in postoperative opioid consumption and pain scores, whereas others have failed to show a benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
IV Lidocaine infusion
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
IV normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
IV Lidocaine infusion
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
IV normal saline infusion
Primary Outcome Measure Information:
Title
Intraoperative bleeding
Description
Will be calculated from the fluid volume of the suction canister. The volume of irrigating fluid will subtracted from the total volume of fluid contained in the suction bottle. Additionally, a fully soaked cotton strip will be assumed to contain 5 ml of blood and a partially soaked one to contain 2-3 ml of blood
Time Frame
Intraoperative assessment till end of operation
Secondary Outcome Measure Information:
Title
Quality of surgical field
Description
The surgeon will assess the quality of surgical field every 15 min after the beginning of drug infusion for the first 60 min according to a 6-point Boezaart scale
Time Frame
intraoperative assessment
Title
Surgeon satisfaction
Description
with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent
Time Frame
At the end of surgery
Title
Mean arterial pressure
Description
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Time Frame
intraoperative assessment
Title
Heart rate
Description
Will be assessed at the initial phase (baseline), immediately after induction of anesthesia, and then 15, 30. 45, 60 min after the begining of drug infusion
Time Frame
intraoperative assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients, 20-50 yr ASA class I and II
Elective Functional endoscopic sinus surgery (FESS) under general anesthesia.
Exclusion Criteria:
Patient refusal, allergy to the study medication, pre-existing chronic pain at any site requiring treatment, intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs), psychiatric or neurological disorders, seizure disorder requiring medication within the previous 2 years, body mass index > 30 kg/ m2, revision sinus surgery, pregnancy, and patients with cardiovascular, cerebrovascular, respiratory, renal or hepatic diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Assuit University
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
Facility Name
Seham Mohamed Moeen Ibrahim
City
Asyut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Lidocaine in ERAS for FESS
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