Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort (CRBD) in patients undergoing non-urologic surgery

Comparison of the effect of hyoscine and EMLA cream on Catheter related bladder discomfort in non-urological surgery

Two arm parallel group randomized trial with blinded participants, outcome assessment and statistical analyst.

The study will assess the effectiveness of Hyoscine on CRBD compared to the EMLA group. The participants will assign equally to the groups. This study will carry out at Bohlool Hospital affiliated to Gonabad University of Medical Sciences. The participants, outcome assessment and statistical analyst will blind to the groups.

Having ASA class 1 or 2 , 18 to 60 years old, Elective surgery, general anesthesia and requires urinary catheterization, No history of bladder obstruction, overactive bladder, kidney and liver diseases, chronic pain, cerebrovascular disorders, cardiovascular diseases, psychosis, neurological bladder. Non-urological surgeries. No history of allergy to lidocaine or prilocaine and hyoscine, No cardiac dysrhythmia. No obvious cognitive impairment Do not take sedatives for a long time. No kidney or liver failure. No history of drug use. No untreated glaucoma, active bleeding, Paralytic ileus, chronic lung disease and secondary tachycardia due to heart failure. Medications used before and during anesthesia should be the same. Unwillingness to cooperate. Patients should also undergo urological surgery during the operation. Any effective intervention or medication in addition to medications used in the routine anesthesia process

group 1: Hyoscine N-butyl bromide, at a dose of 20 mg intravenously within one minute before extubating. group 2, 5 g of EMLA cream and group 3 (control): 5 g of Lidocaine jell, both of these is made in Iran, applicating before placing a urinary catheter for a patient

Incidence of CRBD

Adding control group to study, changing the measurement time and modifying randomization mode and sample size

After obtaining written consent from the participants, the patients were selected through purposive sampling method and were randomly assigned to control and intervention groups based on the permutation blocks method. To do this, the letter C, B and A will be considered for the 2% lidocaine gel (control group), EMLA and Hyoscine + lidocaine groups, respectively. Possible modes in permutation blocks method are six modes include (BCA, ACB, ABC, BAC, CBA, and CAB). Each mode will be written on a card and the cards will be assigned the number one to six. Then 35 mode is selected by using a table of random numbers, 35 numbers between 1 and 6 will be selected. The resulting blocks will be listed in order. Then, based on the list, the selected patients are divided into three groups. In order to homogenize the gender, a separate list is prepared for each of those.

Prior to anesthesia and allocation to groups, for participants who meet the inclusion criteria will be described control and two intervention groups. The participants will be explained that they will allocate into two interventions or control groups. At the end of the study, they are informed about their group. The evaluator of primary (CRBD) and secondary outcomes (severity of CRBD) will be a person (Apart from the main researchers) who does not know the patient is in the intervention or control groups. One, two and three will assign to two interventions and control groups, respectively. Therefore, the statistical analyst will not aware of the study groups and only will know the groups as a code.

Thesis report All research information will be published after being unidentified.

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