Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

Study Overview
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Brief Summary
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This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.

Official Title
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Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries

Conditions
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Aminophylline, Pain, Ureterocopic Lithotripsy

Intervention / Treatment
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* Drug: Aminophylline group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 to 50 years American society of anesthesiology (ASA) physical status I - II Body mass index (BMI) less than 30.0 kg/m2 Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure Under general anesthesia. Exclusion Criteria: Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction. Pregnancy or lactation. Patients with a history of allergy to aminophylline. Coffee consumption (more than 2 cups/day) Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aminophylline group<br>Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position. | Drug: Aminophylline group<br>* Patients will receive 4 mg/kg aminophylline diluted in 100 ml normal saline over 20 minutes after induction of anesthesia and positioning of patients in lithotomy position.<br>|
| Placebo Comparator: Control group<br>Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning. | Other: Control group<br>* Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery. | In post anesthesia care unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | Visual analogue score (VAS) score: will be measured on arrival to PACU, at 30 minutes, 1 hour, 2 hour, 6, 12 and 24 hour after surgery. | 24 hour after surgery | 
| Total amount of opioid dose | If Patients reported VAS score more than 3, they will receive intravenous 0.5 mg /kg pethidine. All patients will be observed in PACU for at least 2 hour and in the ward on the day of surgery for confirming any side effects or complications. | 24 hour after surgery | 
| The incidence of postoperative adverse reactions | the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups. | 24 hour after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aminophylline, Postoperative Pain, Ureterocopic Lithotripsy