Lidocaine in ERAS for FESS

NCT ID: NCT03047070

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-09
• Study Completion Date: 2021-12-31

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.

Conditions

Intraoperative Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Lidocaine

IV Lidocaine infusion

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

IV Lidocaine infusion

Control

IV normal saline infusion

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

IV normal saline infusion

Interventions

Lidocaine

IV Lidocaine infusion

Intervention Type: DRUG

Normal saline

IV normal saline infusion

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Seham Mohamed Moeen Ibrahim

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seham M Moeen, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Faculty of Medicine Assuit University

Asyut, Assuit, Egypt

Seham Mohamed Moeen Ibrahim

Asyut, , Egypt

Countries

Egypt

Other Identifiers

SM22017

Identifier Type: -

Identifier Source: org_study_id