The effect of the combined topical gel containing diltiazem, papaverine and lidocaine on hand function, pain, radial artery spasm and sympathetic tone in patients undergoing Trans radial cardiac catheterization

Determining the effect of combined topical gel of diltiazem, papaverine and lidocaine on hand function, pain, radial artery spasm and sympathetic tone in patients undergoing radial cardiac catheterization.

A clinical trial with a control group with a three-blind parallel group, randomized by block method, phase 3 of the trial on 48 patients who are candidates for PCI.

The Cath-Lab and CCU department will be in Imam Khomeini Hospital (RA) of Amol city. Patients will be divided into two groups of patients receiving the combined topical gel (A) and the placebo group (B) using a randomized block and triple-blind method. 30 to 60 minutes before the radial artery catheterization, a certain amount (fingertip) of the combined gel is applied in the right wrist area, the location of the radial artery pulse in the intervention group, and the same amount of placebo is applied in the control group. After the patients are admitted to the lab, catheterization is performed by the attending physician. Catheterization of all patients will be performed by the attending physician. Before, during and after radial artery catheterization, pain and sympathetic tone will be evaluated in two groups. Hand function will be evaluated before and two hours after catheter removal (after TR BAND removal). Occurrence of radial artery spasm is also checked during catheterization.

1. Patients with coronary heart disease and clinical candidates for radial catheterization for diagnostic or therapeutic intervention. 2. Able to understand Persian language 3. Providing written consent 4. Age over 18 years 5. Absence of pain and previous injury in the right hand

Topical gel recipient

Radial artery spasm, hand function, pain, sympathetic tone

Patients will be placed in one of the two test groups (receiver of combined topical gel of diltiazem, papaverine and lidocaine) and control (placebo) by block randomization method. According to the 6 possible ways of placing letters in blocks of four, these blocks are numbered with numbers one to six. . (AABB1-ABBA2-BABA3-BBAA4-BABA5-ABAB6) Then, using Random Allocation Software 2.0, one of the numbers one to six will be randomly selected for 12 times. Each number will specify four placement modes in a block. Blocks of four will be placed in 12 non-transparent envelopes in numbered order according to the sequence of random selection and these envelopes will be sealed by someone outside the research team who is unaware of the research objectives and the allocation of people to the groups under study. . The envelopes will be opened in order and the patients will be assigned to the respective groups.

It is in the form of three blinds. That is, both the participant and the researchers and the interventionist doctor and the nurse collecting the data will be blind to the placement of the patient in the intervention or placebo group. For this purpose, the drug and placebo will be prepared in same shape and without name labels tubes. These tubes are tagged A and B. Only the principal researcher will know which tube contains drug and which placebo. The patient, nurse and doctor of Cat.Lab. department, data collector and even the statistical analyzer will be unaware of the tubes contents. Patients will be randomly assigned to one of A or B groups in a block method.

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