Lidocaine in ERAS for FESS

Intraoperative Bleeding Clinical Trial

Official title:

Lidocaine Infusion in Functional Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047070
• Other study ID #: SM22017
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding

Intervention

Drug:
• Lidocaine
IV Lidocaine infusion
• Normal saline
IV normal saline infusion

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Assuit University	Assiut	Assuit
Egypt	Seham Mohamed Moeen Ibrahim	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative assessment till end of operation
Secondary	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	intraoperative assessment
Secondary	Surgeon satisfaction	with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent	At the end of surgery
Secondary	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	intraoperative assessment
Secondary	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	intraoperative assessment