Back to resultsThe Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
Primary Purpose
Renal Stone
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Marcaine Injectable Product
Sponsored by
About this trial
This is an interventional other trial for Renal Stone
Eligibility Criteria
Inclusion Criteria:
- 18-70 years of age
- body mass index <35,
- renal stone size >2.0 cm.
Exclusion Criteria:
- patients having supra-costal puncture.
- excessive intraoperative bleeding.
- renal stones requiring more than a single puncture.
- surgical procedure extending more than 3 hours.
- urinary tract infection.
- severe cardiopulmonary disease.
- abnormal renal function tests.
- allergy to local anesthetics.
Sites / Locations
- Saddam Al Demour
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
study group :infiltration with 0.25% bupivacaine post-op
control group , no anesthesia infiltration post-op
Arm Description
At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin
control group: no anesthesia infiltration had been given post opertatively
Outcomes
Primary Outcome Measures
visual analogue scale (VAS )
Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours
Dynamic Visual Analogue Scale (DVAS)
Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours
Secondary Outcome Measures
The time for the first opioid demand
first post op time for analgesia
the number of opioid demands
total number of opioid given to the patient
total opioid consumption
total amount of opioid consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160936
Brief Title
The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
Official Title
The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
September 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saddam Al Demour
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.
Detailed Description
The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group :infiltration with 0.25% bupivacaine post-op
Arm Type
Active Comparator
Arm Description
At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin
Arm Title
control group , no anesthesia infiltration post-op
Arm Type
No Intervention
Arm Description
control group: no anesthesia infiltration had been given post opertatively
Intervention Type
Drug
Intervention Name(s)
Marcaine Injectable Product
Other Intervention Name(s)
Sensorcaine Injectable Product
Intervention Description
Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration
Primary Outcome Measure Information:
Title
visual analogue scale (VAS )
Description
Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours
Time Frame
1, 4, 8, 12, 24, and 48 hours
Title
Dynamic Visual Analogue Scale (DVAS)
Description
Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours
Time Frame
1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours
Secondary Outcome Measure Information:
Title
The time for the first opioid demand
Description
first post op time for analgesia
Time Frame
48 hours
Title
the number of opioid demands
Description
total number of opioid given to the patient
Time Frame
48 hours
Title
total opioid consumption
Description
total amount of opioid consumption
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years of age
body mass index <35,
renal stone size >2.0 cm.
Exclusion Criteria:
patients having supra-costal puncture.
excessive intraoperative bleeding.
renal stones requiring more than a single puncture.
surgical procedure extending more than 3 hours.
urinary tract infection.
severe cardiopulmonary disease.
abnormal renal function tests.
allergy to local anesthetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddam AlDemour, professor
Organizational Affiliation
The University of Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saddam Al Demour
City
Amman
ZIP/Postal Code
11942
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no IPD sharing plan
Learn more about this trial
The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy
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