Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

Not Applicable

Completed

• Conditions: Pain; Ureterocopic Lithotripsy; Aminophylline
• Interventions: Drug: Aminophylline group; Other: Control group

• Registration Number: NCT05705050
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-21
• Study First Submitted QC: 2023-01-21
• Study First Posted: 2023-01-30
• Study Start: 2023-02-15
• Status Verified: 2023-06
• Primary Completion: 2023-06-18
• Study Completion: 2023-06-19
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

1. Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
2. Pregnancy or lactation.
3. Patients with a history of allergy to aminophylline.
4. Coffee consumption (more than 2 cups/day)
5. Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
6. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aminophylline group	Aminophylline group	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.
Control group	Control group	Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	In post anesthesia care unit (PACU)	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.

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative adverse reactions	24 hour after surgery	the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups.
Intensity of pain	24 hour after surgery	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.
Total amount of opioid dose	24 hour after surgery	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.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, ElGharbiaa, Egypt