Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705050
• Other study ID #: 36264PR19/1/23
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 19, 2023

Study information

• Verified date: June 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 19, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Other:
• Control group
Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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