Arteriovenous Graft Site PainPhase 3NCT05822063
The Effect of Cold Packs, Lidocaine and Flash Lights on Cannulation Pain in Hemodialysis Patients
A Phase 3 study testing Lidocaine topical, cold packs and flash lights in people with Arteriovenous Graft Site Pain, run by Ain Shams University.
Trial summary
Compare the effects of lidocaine ,ice packs and flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arteriovenous Graft Site Pain
- What is being tested?
- Lidocaine topical, cold packs and flash lights
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2023to 1 Sep 2023
- Phase
- Phase 3
- 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 will be willing to participate in the study.
- Patients who are diagnosed as chronic kidney disease \& undergoing haemodialysis with A.V. fistula of upper extremity currently used for haemodialysis which can be radio cephalic, radio basilic or brachio cephalic.
- Chronic kidney disease patients who are visiting regularly, minimum 2 times per week for haemodialysis.
Who cannot join
- 1. Chronic kidney disease patients who are undergoing haemodialysis with other vascular access than A.V. fistula access.
- 4. Patients who are allergic to cold therapy.
About this study
Official title: The Effect of Cold Packs, Lidocaine and Flash Lights on Cannulation Pain in Hemodialysis
Compare the effects of lidocaine ,ice packs and flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients.
Read the detailed description
Chronic dialysis requires access to safe vessels that can be used for months; therefore, an arteriovenous fistula [AVF] is an appropriate option. Despite positive points, AVF has some disadvantages in comparison with other vascular access methods, including the inevitable pain of needle insertion in the fistula Each dialysis patient undergoes dialysis of approximately 3 times a week and 3 to 4 hours each time, which inevitably tolerates the pain caused by AVF cannulation 3 times a week. This pain will accompany these patients until the end of life unless they perform kidney transplantation
Half of dialysis patients express dissatisfaction with the experience of various types of pain, especially pain caused by AVF cannulation Reports have shown that 47% of dialysis patients, in addition to fear of cannulation pain, expressed this stage as the most stressful part of dialysis The main cause of this fear and apprehension is the diameter and length of the needle used for cannulation Repeated pain induced by hemodialysis fistula cannulation may lead to depression, reduced quality of life, pain, discomfort, distress, and stress, while controlling the pain improves the patients' acceptance of hemodialysis and their quality of life Considering the significance of pain, algesia relief must be considered as one part of treatment in these patients Presently, there is no uniform method to be used for relieving arteriovenous fistula cannulation pain in patients undergoing hemodialysis (Nasirzadeh, MircheraghI et al. 2019). There are various pharmacologic and nonpharmacologic modalities for pain relief. The effectiveness of some of these methods in relieving pain is still in under question.
Some of the puncture-related pain relief methods reported in literature include the application of heat or cold, EMLA local anesthesia creams, distraction methods, lidocaine gel, and lavender aroma inhalation
Ice pack and EMLA cream are two examples of local anesthetics which are readily applicable by the patients themselves . Ice is cheap and easily available with rapid and simple use which decreases pain by attenuating the signals of pain sensation, increasing perception of cold sensation instead of pain, and reducing the speed of neural transmission with pain neural fibers Lidocaine is one of the important common agents used as a local anesthetic . Lidocaine spray is one of the common formulations used clinically with moderate-term effect to induce local anesthesia in mucous membranes and skin. Depending on the site of application, anesthesia is usually induced during 1-5 min lasting for 10-15 min The EMLA cream as a local anesthetic contains lidocaine 25 mg/g and prilocaine 25 mg/g with little complications like slight redness of the site. It produces anesthesia of 5 mm depth . The theory behind pain reduction by lidocaine is the blocking of active and inactive sodium channels resulting in blockade of conduction and absence of stimulation followed by impaired or reduced pain transmission
Cutaneous stimulation includes cryotherapy thermotherapy, massage, pressure, and vibration, may help patients to relax or distract them from their pain. The term cryotherapy comes from the Greek ward cryo means cold and therapy means cure. Cryotherapy is the application of superficial cold \& it is considered as a best cutaneous stimulation technique in terms of pain reduction. Applying cold will numb the area providing pain relief, reduce swelling and decrease metabolic rate reducing the oxygen requirements of the injured cells In the recent literature, venous cannulation pain after a flash of light has been shown to reduce the pain. During pain conditions, thalamic stimulation causes modulation of nociceptive information, leading to a reduction in pain perception. Thalamus is an integral part of the light reflex; it was presumed that a flash of light, by initiating a light reflex, might cause thalamic stimulation and thus decrease venous cannulation pain
Considering the contradictory results of these studies and regarding the importance of pain control in hemodialysis patients, this study explored the effect of lidocaine-containing compounds , ice pack, flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients.
- Conditions
- Arteriovenous Graft Site Pain
- Being tested
- Lidocaine topical, cold packs, flash lights
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topicalDrug
Also called lidocaine spray
lidocaine spray
cold packsOther
ice packs
flash lightsDevice
flash lights by camera
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | the skin site will be prepped first and then two puffs of lidocaine (20 mg) will be sprayed by the researcher from a 5-cm distance on the dermal surface near the needle insertion point. Five minutes after spraying, the skin surface at the site of arterial needle insertion will be disinfected with 70% alcohol-soaked cotton pads and the specific hemodialysis needles will be inserted into the vessels of the fistula area by the ward nurse Receives: Drug: Lidocaine topical |
| cold packs | Active comparator | In the ice pack method, 5 pieces of ice measuring 5*5 will be placed in latex gloves and covered with material cover. They were placed after the passage of 2 min on the hand at the site of fistula 5 min before making the puncture. Next, specific hemodialysis needles will be inserted in the vessels of fistula area by the ward nurse after disinfecting the fistula area with 70% alcohol-soaked cotton pads. Receives: Other: cold packs |
| flash lights | Active comparator | the patient's face will be photographed. The photograph will be taken with a camera [(Sony HVLHFL1 with luminance intensity approximately 100 cd, lighting distance approximately 11 Lux, flash shooting distance (1-5 m)]. Receives: Device: flash lights |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale(VAS)
it is score 1 to 10 according to pain intensity( 1= better ,10= worst)
Measured: one month ( 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start25 Jul 2023 (estimated)
- Primary completion25 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Graft Site PainStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Farid, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822063
- Sponsor's protocol ID
- FAMASU/2023
- Status last verified
- Jul 2023
- First submitted
- 6 Apr 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Packs, Lidocaine and Flash Lights on Cannulation Pain in Hemodialysis
- ClinicalTrials.gov ID
- NCT05822063
- Acronym / sponsor ID
- FAMASU/2023
- Conditions
- Arteriovenous Graft Site Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 20 Apr 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.
Compare the effects of lidocaine ,ice packs and flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients.
Detailed description
Chronic dialysis requires access to safe vessels that can be used for months; therefore, an arteriovenous fistula [AVF] is an appropriate option. Despite positive points, AVF has some disadvantages in comparison with other vascular access methods, including the inevitable pain of needle insertion in the fistula Each dialysis patient undergoes dialysis of approximately 3 times a week and 3 to 4 hours each time, which inevitably tolerates the pain caused by AVF cannulation 3 times a week. This pain will accompany these patients until the end of life unless they perform kidney transplantation
Half of dialysis patients express dissatisfaction with the experience of various types of pain, especially pain caused by AVF cannulation Reports have shown that 47% of dialysis patients, in addition to fear of cannulation pain, expressed this stage as the most stressful part of dialysis The main cause of this fear and apprehension is the diameter and length of the needle used for cannulation Repeated pain induced by hemodialysis fistula cannulation may lead to depression, reduced quality of life, pain, discomfort, distress, and stress, while controlling the pain improves the patients' acceptance of hemodialysis and their quality of life Considering the significance of pain, algesia relief must be considered as one part of treatment in these patients Presently, there is no uniform method to be used for relieving arteriovenous fistula cannulation pain in patients undergoing hemodialysis (Nasirzadeh, MircheraghI et al. 2019). There are various pharmacologic and nonpharmacologic modalities for pain relief. The effectiveness of some of these methods in relieving pain is still in under question.
Some of the puncture-related pain relief methods reported in literature include the application of heat or cold, EMLA local anesthesia creams, distraction methods, lidocaine gel, and lavender aroma inhalation
Ice pack and EMLA cream are two examples of local anesthetics which are readily applicable by the patients themselves . Ice is cheap and easily available with rapid and simple use which decreases pain by attenuating the signals of pain sensation, increasing perception of cold sensation instead of pain, and reducing the speed of neural transmission with pain neural fibers Lidocaine is one of the important common agents used as a local anesthetic . Lidocaine spray is one of the common formulations used clinically with moderate-term effect to induce local anesthesia in mucous membranes and skin. Depending on the site of application, anesthesia is usually induced during 1-5 min lasting for 10-15 min The EMLA cream as a local anesthetic contains lidocaine 25 mg/g and prilocaine 25 mg/g with little complications like slight redness of the site. It produces anesthesia of 5 mm depth . The theory behind pain reduction by lidocaine is the blocking of active and inactive sodium channels resulting in blockade of conduction and absence of stimulation followed by impaired or reduced pain transmission
Cutaneous stimulation includes cryotherapy thermotherapy, massage, pressure, and vibration, may help patients to relax or distract them from their pain. The term cryotherapy comes from the Greek ward cryo means cold and therapy means cure. Cryotherapy is the application of superficial cold \& it is considered as a best cutaneous stimulation technique in terms of pain reduction. Applying cold will numb the area providing pain relief, reduce swelling and decrease metabolic rate reducing the oxygen requirements of the injured cells In the recent literature, venous cannulation pain after a flash of light has been shown to reduce the pain. During pain conditions, thalamic stimulation causes modulation of nociceptive information, leading to a reduction in pain perception. Thalamus is an integral part of the light reflex; it was presumed that a flash of light, by initiating a light reflex, might cause thalamic stimulation and thus decrease venous cannulation pain
Considering the contradictory results of these studies and regarding the importance of pain control in hemodialysis patients, this study explored the effect of lidocaine-containing compounds , ice pack, flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: Lidocaine topicalthe skin site will be prepped first and then two puffs of lidocaine (20 mg) will be sprayed by the researcher from a 5-cm distance on the dermal surface near the needle insertion point. Five minutes after spraying, the skin surface at the site of arterial needle insertion will be disinfected with 70% alcohol-soaked cotton pads and the specific hemodialysis needles will be inserted into the vessels of the fistula area by the ward nurse |
| cold packs | Active comparator | Other: cold packsIn the ice pack method, 5 pieces of ice measuring 5*5 will be placed in latex gloves and covered with material cover. They were placed after the passage of 2 min on the hand at the site of fistula 5 min before making the puncture. Next, specific hemodialysis needles will be inserted in the vessels of fistula area by the ward nurse after disinfecting the fistula area with 70% alcohol-soaked cotton pads. |
| flash lights | Active comparator | Device: flash lightsthe patient's face will be photographed. The photograph will be taken with a camera [(Sony HVLHFL1 with luminance intensity approximately 100 cd, lighting distance approximately 11 Lux, flash shooting distance (1-5 m)]. |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be willing to participate in the study.
- Patients who are diagnosed as chronic kidney disease \& undergoing haemodialysis with A.V. fistula of upper extremity currently used for haemodialysis which can be radio cephalic, radio basilic or brachio cephalic.
- Chronic kidney disease patients who are visiting regularly, minimum 2 times per week for haemodialysis.
Key exclusion criteria (2 listed)
- 1. Chronic kidney disease patients who are undergoing haemodialysis with other vascular access than A.V. fistula access.
- 4. Patients who are allergic to cold therapy.
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 topicalAlso: lidocaine spraylidocaine spray | Drug | Lidocaine group |
| cold packsice packs | Other | cold packs |
| flash lightsflash lights by camera | Device | flash lights |
Primary outcome
Visual analogue scale(VAS)
Time frame: one month ( 30 days)
it is score 1 to 10 according to pain intensity( 1= better ,10= worst)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine topical, cold packs and flash lights in people with Arteriovenous Graft Site Pain, run by Ain Shams University.
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 3 inclusion and 2 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale(VAS) (time frame: one month ( 30 days)). 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 20 Jul 2023.