Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Aminophylline; Ureterocopic Lithotripsy
• Intervention / Treatment: Drug: Aminophylline group; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31527
      • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: Control group; Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.	Other: Control group; Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): June 18, 2023
• Study Completion (Actual): June 19, 2023

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Aminophylline; Ureterocopic Lithotripsy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Protective Agents; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Aminophylline
• Other Study ID Numbers: 36264PR19/1/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Time Frame: The data will be available 6 months after publication
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No