The Effect of Cold Packs, Lidocaine and Flash Lights on Cannulation Pain in Hemodialysis Patients

NCT ID: NCT05822063

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2023-09-01

Brief Summary

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.

Conditions

Arteriovenous Graft Site Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine group

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

Group Type: ACTIVE_COMPARATOR

Lidocaine topical

Intervention Type: DRUG

lidocaine spray

cold packs

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.

Group Type: ACTIVE_COMPARATOR

cold packs

Intervention Type: OTHER

ice packs

flash lights

the patient's face will be photographed. The photograph will be taken with a camera \[(Sony HVLHFL1 with luminance intensity approximately 100 cd, lighting distance approximately 11 Lux, flash shooting distance (1-5 m)\].

Group Type: ACTIVE_COMPARATOR

flash lights

Intervention Type: DEVICE

flash lights by camera

control

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine topical

lidocaine spray

Intervention Type: DRUG

cold packs

ice packs

Intervention Type: OTHER

flash lights

flash lights by camera

Intervention Type: DEVICE

Other Intervention Names

lidocaine spray

Eligibility Criteria

Inclusion Criteria

1. Patients who will be willing to participate in the study.

2. 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.

3. Chronic kidney disease patients who are visiting regularly, minimum 2 times per week for haemodialysis.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Farid

lecturer in clinical pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FAMASU/2023

Identifier Type: -

Identifier Source: org_study_id