Infiltration of Diphenhydramine versus subcutaneous Lidocaine at the wound site to reduce pain after open renal surgeries

Determination of analgesic effect of diphenhydramine injection on the edge of surgical wound after open renal surgery

A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 2-3 on 60 patients. Block randomization method was used for randomization.

This double-blind clinical trial will be conducted on 60 male-female patients who are candidates for open renal surgeries with flank incision at Sina Hospital in Tehran. The patients are divided into two groups by Block balanced randomization. This study is double blind clinical trial. Outcome analyser , the outcome evaluator and the participant are blinded (double blind).

Inclusion criteria: patients candidate for open renal surgery , Patients who consent to participate in the study. Exclusion criteria: History of allergy to lidocaine or diphenhydramine,History of sleep apnea, history of drug addiction,or other psychedelic drugs,History of acute drug or alcohol intoxication, history of psychological disorder

Intervention group 10 ml of normal saline containing 10 mg/ml diphenhydramine is injected into the edge of the surgical wound under the skin before the wound is completely closed. control group:10 ml of normal saline containing 10/ml mg lidocaine is injected at the edge of the surgical wound under the skin before the wound is completely closed.

Acute Postoperative Pain, Agitation and Sedation degree, The first time requires analgesia after surgery, The total amount of analgesic consumption after surgery

In order to randomize, a random block method will be used. For this purpose, we formed blocks of size 4. In each block, 2 individuals will be in intervention group 1 and 2 will be in intervention group 2. A total of 20 blocks will be considered for the study. All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 20 blocks to select 80 people. We randomly select these blocks from 1 to 6. Using the software, we choose a random number between the numbers 1 to 6. For example, if the number 6 is selected as the first block and the number 2 as the second block, the people who enter the study will be given BAABAABB, respectively. Finally, group A receives control intervention and group B receives treatment intervention.

In this study, patients do not know their group.Eligible participants were assigned to receive either lidocaine (group L) or diphenhydramine as (group D) according to a computer-generated randomization schedule. These medications are prepared in identical syringes and volumes and are identified with the patient name and hospital registration number. At the end of the surgery, these drugs are given to the surgeon for injection, who is blinded to the allocation groups. Another researcher who is blinded to the assigned group will assess the severity of pain in the recovery room and ward.

Main study outcome data

Six months after the end of the study

University researchers

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