AnesthesiaPhase 4NCT06184958
Potential Role of Intravenous Lidocaine Versus Intravenous Ketamine for Pain Management in Fibromyalgia Patients
A Phase 4 study testing Lidocaine group and Ketamine group in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous ketamine in treatment of fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Lidocaine group and Ketamine group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2023to Mar 2024
- Phase
- Phase 4
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with FM, diagnosed according to the American College of Rheumatology (ACR) 2016 diagnostic criteria for FM. (Wolfe, F., Clauw, D. J., Fitzcharles, M. A., et al., 2016)
Who cannot join
- - Known hypersensitivity to any of the given drugs or one of their derivatives (lidocaine or ketamine).
- Known Arrhythmia (Supraventricular or ventricular).
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
maha sadek El Derh
Cairo, 11721
maha S El Derh, MD, 01144866675, mahasadek81@yahoo.com
reham hashim, MD, 01003072065, dr_reham80@yahoo.com
About this study
The aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous ketamine in treatment of fibromyalgia patients.
Read the detailed description
Adult fibromyalgia patients (25 to 50 years old) suffering from with uncontrolled pain perception will be enrolled although maximum medical treatment is prescribed.
Pre-procedure study tools:
- patients are on regular medical treatment in the form of Cymbalta 60 mg/day, Triptyzol 25 mg/day, and Gabapantin 100 mg/day.
- The following will be done for all the patients:
- Full medical history.
- Thorough clinical examination.
- Visual analogue scale for pain assessment pre and post administration of the study medications.
- FM impact Questionnaire (FIQR) for assessment quality of life pre and post administration of the study medications.
- ECG.
- Laboratory Investigations will include:
Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) with Westergren blot method in (mm) after 1st hour (mm/1st hour).
C-reactive protein (CRP) in (mg/dl) by latex method. Kidney function tests. Liver enzymes. Rheumatoid factor (RF). Anti-nuclear antibody titer (ANA) by indirect immunofluorescence (IIF).
Patients' recruitment, randomization and control of potential bias The sealed, opaque, sequentially-numbered envelopes method for randomization and allocation concealment will used. Identical, opaque, letter-sized envelopes; each containing a white allocation paper (Marked as "Treatment A") will used and a sheet of single-sided carbon paper closest to the front of the envelope (with the carbon side facing the white paper). Finally, the envelopes will be sealed, with signing across the seal. Likewise, another 2 sets will be prepared 25 "Treatment B" envelopes and "Treatment C" envelopes. The three sets (envelopes) will be combined and shuffled thoroughly. Using a pen, marking a number will be done on the front of each envelope sequentially from 1 to 75. Then, will place these envelopes into a plastic container, in numerical order, ready for use.
An investigator (not involved in sequence generation and allocation concealment) will assess patients for eligibility and assigned eligible patients to either lidocaine intravenous infusion (Group A) , ketamine infusion (Group B) or placebo infusion (group C). Participants, care providers, outcomes assessors, and data analysts will be ignorant of the treatment allocation.
All patients will have an intravenous access with a 20G cannula and will be monitored by pulse oximetry, electrocardiogram and non-invasive blood measurement (every 5 minutes). They will be randomly assigned into one of the following three groups:
GROUP A: ( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
GROUP B: ( 25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
Group C: ( 25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
All patients will be monitored to detect any abnormalities either due to hypersensitivity of the patients or due to potential side effects of lidocaine such as dizziness, fatigue, headache, itchy, warm or red skin, or due to ketamine example hallucination (aborted by 1 mg midazolam), nausea or vomiting, panic attack or memory problems.
- Conditions
- Anesthesia
- Being tested
- Lidocaine group, Ketamine group, Placebo group
- Keywords
- Fibromyalgia,Ketamine, Lidocaine
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine groupDrug
Group A: Lidocaine group( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
Ketamine groupDrug
Group B:Ketamine group(25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
Placebo groupDrug
Group C:placebo group (25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A:Lidocaine group | Active comparator | 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks Receives: Drug: Lidocaine group |
| Group B:Ketamine group | Active comparator | 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. Receives: Drug: Ketamine group |
| Group C:Placebo group | Placebo comparator | Placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. Receives: Drug: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
: Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS).
Questionnaire to assess degree of pain relieve and improvement of physical activity, a scale from 0-10 where 0 is no pain or limitation and 10 is the worst unbearable pain perception. Asucess is achieved when decline in the scale takes place 3 points out of 10 , where at least reach 5
Measured: Assessment will be done weekly for 3 weeks. First assessment will be 1week after first procedure ,on the same day of 2nd injection. 2nd assessment will be on the same day of the 3rd injection . 3rd assessment will be done 1 week after third injection
Secondary outcomes (1)
: Quality of life questionnaire that measures the patients' physical and psychological well-being.
Health related quality of life questionnaire its simplified (HRQOL S36) will be used to quantify degree of improvement of physical and psychological well being.The questionnaire is formed of 8 domains,each domain is scaled from 0-100,0 is the worst disability and 100 is the best .Patient is said to be improved when improvemnt of 30% baseline take place
Measured: Pre-procedure measurement and another measurement will be assessed one month after first procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start2 Sep 2023
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha sadek El Derh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184958
- Sponsor's protocol ID
- FMASUR332/2023
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Intravenous Lidocaine Versus Intravenous Ketamine for Pain Management in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT06184958
- Acronym / sponsor ID
- FMASUR332/2023
- Conditions
- Anesthesia
- Keywords
- Fibromyalgia,Ketamine, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Sep 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 29 Dec 2023 (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 aim of the study is to assess the efficacy of intravenous lidocaine versus intravenous ketamine in treatment of fibromyalgia patients.
Detailed description
Adult fibromyalgia patients (25 to 50 years old) suffering from with uncontrolled pain perception will be enrolled although maximum medical treatment is prescribed.
Pre-procedure study tools:
- patients are on regular medical treatment in the form of Cymbalta 60 mg/day, Triptyzol 25 mg/day, and Gabapantin 100 mg/day.
- The following will be done for all the patients:
- Full medical history.
- Thorough clinical examination.
- Visual analogue scale for pain assessment pre and post administration of the study medications.
- FM impact Questionnaire (FIQR) for assessment quality of life pre and post administration of the study medications.
- ECG.
- Laboratory Investigations will include:
Complete blood count (CBC) Erythrocyte sedimentation rate (ESR) with Westergren blot method in (mm) after 1st hour (mm/1st hour).
C-reactive protein (CRP) in (mg/dl) by latex method. Kidney function tests. Liver enzymes. Rheumatoid factor (RF). Anti-nuclear antibody titer (ANA) by indirect immunofluorescence (IIF).
Patients' recruitment, randomization and control of potential bias The sealed, opaque, sequentially-numbered envelopes method for randomization and allocation concealment will used. Identical, opaque, letter-sized envelopes; each containing a white allocation paper (Marked as "Treatment A") will used and a sheet of single-sided carbon paper closest to the front of the envelope (with the carbon side facing the white paper). Finally, the envelopes will be sealed, with signing across the seal. Likewise, another 2 sets will be prepared 25 "Treatment B" envelopes and "Treatment C" envelopes. The three sets (envelopes) will be combined and shuffled thoroughly. Using a pen, marking a number will be done on the front of each envelope sequentially from 1 to 75. Then, will place these envelopes into a plastic container, in numerical order, ready for use.
An investigator (not involved in sequence generation and allocation concealment) will assess patients for eligibility and assigned eligible patients to either lidocaine intravenous infusion (Group A) , ketamine infusion (Group B) or placebo infusion (group C). Participants, care providers, outcomes assessors, and data analysts will be ignorant of the treatment allocation.
All patients will have an intravenous access with a 20G cannula and will be monitored by pulse oximetry, electrocardiogram and non-invasive blood measurement (every 5 minutes). They will be randomly assigned into one of the following three groups:
GROUP A: ( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
GROUP B: ( 25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
Group C: ( 25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks.
All patients will be monitored to detect any abnormalities either due to hypersensitivity of the patients or due to potential side effects of lidocaine such as dizziness, fatigue, headache, itchy, warm or red skin, or due to ketamine example hallucination (aborted by 1 mg midazolam), nausea or vomiting, panic attack or memory problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A:Lidocaine group | Active comparator | Drug: Lidocaine group5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks |
| Group B:Ketamine group | Active comparator | Drug: Ketamine group0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. |
| Group C:Placebo group | Placebo comparator | Drug: Placebo groupPlacebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with FM, diagnosed according to the American College of Rheumatology (ACR) 2016 diagnostic criteria for FM. (Wolfe, F., Clauw, D. J., Fitzcharles, M. A., et al., 2016)
Key exclusion criteria (3 listed)
- - Known hypersensitivity to any of the given drugs or one of their derivatives (lidocaine or ketamine).
- Known Arrhythmia (Supraventricular or ventricular).
- Pregnant females.
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 groupGroup A: Lidocaine group( 25 patients) will receive 5 mg/Kg lidocaine in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. | Drug | Group A:Lidocaine group |
| Ketamine groupGroup B:Ketamine group(25 patients) will receive 0.5 mg/Kg ketamine sulphate in 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks. | Drug | Group B:Ketamine group |
| Placebo groupGroup C:placebo group (25 patients) will receive placebo 100 ml normal saline given in 40 minutes with 20 minutes follow up to obverse any delayed complication. This procedure will be repeated weekly for 3 weeks | Drug | Group C:Placebo group |
Primary outcome
: Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS).
Time frame: Assessment will be done weekly for 3 weeks. First assessment will be 1week after first procedure ,on the same day of 2nd injection. 2nd assessment will be on the same day of the 3rd injection . 3rd assessment will be done 1 week after third injection
Questionnaire to assess degree of pain relieve and improvement of physical activity, a scale from 0-10 where 0 is no pain or limitation and 10 is the worst unbearable pain perception. Asucess is achieved when decline in the scale takes place 3 points out of 10 , where at least reach 5
1 secondary outcome
: Quality of life questionnaire that measures the patients' physical and psychological well-being.
Time frame: Pre-procedure measurement and another measurement will be assessed one month after first procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Lidocaine group and Ketamine group in people with Anesthesia, 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 1 inclusion and 3 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 29 Dec 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Fibromyalgia impact questionnaire with special attention to Visual Analogue Score (VAS). (time frame: Assessment will be done weekly for 3 weeks. First assessment will be 1week after first procedure ,on the same day of 2nd injection. 2nd assessment will be on the same day of the 3rd injection . 3rd assessment will be done 1 week after third injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.