Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus

NCT06243120 | Unknown Early Phase 1 DMC

• 1 other identifier: KACS, KSA: H-08- L-074
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pruritus Caused by Drug

Keywords

Spinal anesthesia; Pruritus; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The percentage of incidence of pruritus

  The whole perioperative period

• body distribution of pruritus

  The whole perioperative period

• local anesthetic toxicity symptoms.

  The whole perioperative period

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Lidocaine IV DRUG

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.

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, 3567, Egypt

Location

Related Publications (1)

• 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.

  PMID: 25730811 BACKGROUND

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabah Ayoub, MD

CONTACT

966563887242; sabah_nageeb@med.asu.edu.eg

Rabah alharbi, jordonian board

CONTACT

966555595373; rabahsa@moh.gov.sa

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Preparation of the used infusion volume will performed by anesthesia specialist in our center not sharing in the study, he is the one who know it is placebo or lidocaine. The infusion performed blindly by the researcher and VAS will be assessed by the circulating nurse inside the theater or the nurse in the PACU. The regression of VAS in comparison to initial pruritus scale will be recorded in both groups. The percentage of incidence of pruritus, body distribution of pruritus, duration of spinal anesthesia and local anesthetic toxicity symptoms will be recorded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Model Details: Randomized, prospective trial on 2 equal groups

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

EG (1)