Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lidocaine and Ketamine Levels in Plasma After Simultaneous Lidocaine/Ketamine Infusions

NCT05906121

Chronic Pain

COMPLETED

Efficacy of Topical Lidocaine/Prilocaine in Pain Management in Pleurocentesis

NCT05984264

Pleural Effusion

UNKNOWN PHASE4

Lidocaine Patches for Attenuating the Pain of Venipuncture Intravenous Cannulation

NCT02061475

We Focus on the Pain of Venipuncture and Intravenous Cannulation

UNKNOWN PHASE2/PHASE3

Lidocaine Analgesia For Removal Of Wound Vac Dressings

NCT01126359

Pain

COMPLETED NA

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

NCT06910241

Laceration of Skin

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pruritus Caused by Drug

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, prospective trial on 2 equal groups

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lidocaine IV

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Lidocaine IV

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No