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Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

Primary Purpose

Aminophylline, Pain, Ureterocopic Lithotripsy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aminophylline group
Control group
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aminophylline focused on measuring Aminophylline, Postoperative Pain, Ureterocopic Lithotripsy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aminophylline group

Control group

Arm Description

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.

Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 21, 2023
Last Updated
June 24, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05705050
Brief Title
Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy
Official Title
Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 18, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aminophylline, Pain, Ureterocopic Lithotripsy
Keywords
Aminophylline, Postoperative Pain, Ureterocopic Lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aminophylline group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.
Intervention Type
Drug
Intervention Name(s)
Aminophylline group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Patients will receive 100 ml normal saline over 20 minutes after induction and lithotomy positioning.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
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.
Time Frame
In post anesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Intensity of pain
Description
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.
Time Frame
24 hour after surgery
Title
Total amount of opioid dose
Description
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.
Time Frame
24 hour after surgery
Title
The incidence of postoperative adverse reactions
Description
the incidence of adverse reactions, such as arrhythmia, postoperative nausea and vomiting (PONV) and postoperative lightheadedness will be recorded in both groups.
Time Frame
24 hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta University Hospitals
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy

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