Pruritus Caused by DrugEarly Phase 1NCT06243120
Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus
A Early Phase 1 study testing Lidocaine IV in people with Pruritus Caused by Drug, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pruritus Caused by Drug
- What is being tested?
- Lidocaine IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pruritus Caused by Drug
- Being tested
- Lidocaine IV
- Keywords
- Spinal anesthesia, Pruritus, Lidocaine
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The whole perioperative period
Secondary outcomes (3)
The percentage of incidence of pruritus
observation
Measured: The whole perioperative period
body distribution of pruritus
observation
Measured: The whole perioperative period
local anesthetic toxicity symptoms.
observation
Measured: The whole perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pruritus Caused by DrugStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, prospective trial on 2 equal groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Nageeb, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243120
- Sponsor's protocol ID
- KACS, KSA: H-08- L-074
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Through the official email
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.
PubMed 25730811
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine for Treating Intrathecal Fentanyl Induced Pruritus
- ClinicalTrials.gov ID
- NCT06243120
- Acronym / sponsor ID
- KACS, KSA: H-08- L-074
- Conditions
- Pruritus Caused by Drug
- Keywords
- Spinal anesthesia, Pruritus, Lidocaine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized, prospective trial on 2 equal groups
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Lidocaine IVThe 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. |
| Control group | Placebo comparator | Drug: Lidocaine IVThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine IVThe 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. | Drug | Control group, Study group |
Primary outcome
regression of VAS in comparison to initial pruritus scale.
Time frame: The whole perioperative period
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.
3 secondary outcomes
The percentage of incidence of pruritus
Time frame: The whole perioperative period
body distribution of pruritus
Time frame: The whole perioperative period
local anesthetic toxicity symptoms.
Time frame: The whole perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 25730811Wang 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.
- Individual participant dataSharing planned: Undecided. Through the official email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lidocaine IV in people with Pruritus Caused by Drug, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabah Ayoub, MD (966563887242, sabah_nageeb@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regression of VAS in comparison to initial pruritus scale. (time frame: The whole perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.