Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus

The study will assess efficacy of intravenous lidocaine 1 mg/kg diluted with 0.9% sodium chloride to a volume of 100 ml to suppress intrathecal fentanyl induced pruritus. This will be compared to control group who will receive 100 ml normal saline as placebo.

The main outcome is regression of initial VAS score with incidence of pruritus.

Study Overview

• Status: Not yet recruiting
• Conditions: Pruritus Caused by Drug
• Intervention / Treatment: Drug: Lidocaine IV

Detailed Description

The study will include adult patients who are admitted for orthopedic operations and Urosurgery who are planned to receive spinal anesthesia. The study will include adult patients aging from 18 to 70 years old. ASA I to III. The study will exclude the patients who receive antihistamine drugs, patients who suffer any type of coagulopathy, patients who are suffering any type of pruritus before receiving spinal anesthesia and patients who are known allergic to lidocaine. All the patients will receive 500 ml ringer lactate as a volume preload. The patients will be monitored by SPO2, Noninvasive blood pressure and ECG. The spinal anesthesia drugs will be hyperbaric bupivacaine (the dose will be adjusted according to the required level of anesthesia) and 25 mic of fentanyl as an additive. The subjects of the study will not receive any type of sedation. If any patient suffered bradycardia associated with hypotension which necessitate management by atropine or ephedrine, he will be excluded from the study.

Before the surgery, patients could cooperate and understand the Visual Analogue Score (VAS) scale. Patients will be explained about the use of VAS for grading the severity of pruritus on a scale of 0 to 10. VAS = 0 means no pain or itching, VAS = 10 means worst sensation and VAS > 4 means it need intervention. The affected areas by itching will be asked.

The study group will receive lidocaine (2%) 1mg/ kg iv diluted by normal saline to a volume of 100 ml. The VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points , it will be considered as a failure.

The control group will receive 100 ml of normal saline as placebo effect and VAS will be assessed in same manner as the study group.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sabah Ayoub, MD; Phone Number: 966563887242; Email: sabah_nageeb@med.asu.edu.eg
• Study Contact Backup: Name: Rabah alharbi, jordonian board; Phone Number: 966555595373; Email: rabahsa@moh.gov.sa

Study Locations

• Egypt
  • Cairo, Egypt, 3567
    • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients who are admitted for orthopedic operations and Urosurgery who are planned to receive spinal anesthesia.
• The study will include adult patients aging from 18 to 70 years old. ASA I to III.

Exclusion Criteria:

• the patients who receive antihistamine drugs
• patients who suffer any type of coagulopathy
• patients who are suffering any type of pruritus before receiving spinal anesthesia
• patients who are known allergic to lidocaine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study group will receive lidocaine (2%) 1mg/ kg iv diluted by normal saline to a volume of 100 ml. The VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points, it is considered as a failure. If intravenous lidocaine failed to manage pruritus after 30 minutes the patient will receive 20 mg intravenous propofol.	Drug: Lidocaine IV; The study group will receive lidocaine (2%) 1mg/ kg iv diluted by normal saline to a volume of 100 ml. The VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points , it will be considered as a failure.
Placebo Comparator: Control group; The control group will receive 100 ml of normal saline as placebo effect and VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points, it is considered as a failure. If intravenous lidocaine failed to manage pruritus after 30 minutes the patient will receive 20 mg intravenous propofol.	Drug: Lidocaine IV; The study group will receive lidocaine (2%) 1mg/ kg iv diluted by normal saline to a volume of 100 ml. The VAS will be assessed every 10 minutes for 60minutes after the treatment. A regression of more than 4 points of VAS score is considered a success and if less than 4 points , it will be considered as a failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
regression of VAS in comparison to initial pruritus scale.	Before the surgery, patients could cooperate and understand the Visual Analogue Score (VAS) scale. The patients will be explained about the use of VAS for grading the severity of pruritus on a scale of 0 to 10. VAS = 0 means no pain or itching, VAS = 10 means worst sensation and VAS > 4 means it needs intervention.	The whole perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of incidence of pruritus	observation	The whole perioperative period
body distribution of pruritus	observation	The whole perioperative period
local anesthetic toxicity symptoms.	observation	The whole perioperative period

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Wang J, Li J, Cao H, Zhou X, Tang Q. Intravenous lidocaine suppresses dexamethasone-induced perineal pruritus during anesthesia induction: a randomized controlled, double blind study. Pak J Pharm Sci. 2015 Mar;28(2):569-72.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Lidocaine; Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: KACS, KSA: H-08- L-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Through the official email

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No