Lidocaine in ERAS for FESS

Phase 2

Completed

• Conditions: Intraoperative Bleeding
• Interventions: Drug: Lidocaine; Drug: Normal saline

• Registration Number: NCT03047070
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-06
• Study First Posted: 2017-02-08
• Study Start: 2017-02-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	IV Lidocaine infusion
Control	Normal saline	IV normal saline infusion

Primary Outcome Measures

Name	Time	Method
Intraoperative bleeding	Intraoperative assessment till end of operation	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

Name	Time	Method
Surgeon satisfaction	At the end of surgery	with a 4-point scale: 1 = Poor, 2 = Moderate, 3 = Good, 4 = Excellent
Heart rate	intraoperative assessment	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
Mean arterial pressure	intraoperative assessment	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
Quality of surgical field	intraoperative assessment	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

Trial Locations

Locations (2)

Seham Mohamed Moeen Ibrahim; 🇪🇬 Asyut, Egypt

Faculty of Medicine Assuit University; 🇪🇬 Assiut, Assuit, Egypt