Back to resultsComparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
Primary Purpose
Pain, Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Local anesthesia, Percutaneous nephrolithotomy.
Eligibility Criteria
Inclusion Criteria:
- all patients undergoing PCNL
- age from 12-65 years
- normal renal functions
- no history of chronic pain
- ASA I, II & III
- Both genders
Exclusion Criteria:
- history of local anaesthesia allergy
- Redo PCNL
- Multiple punctures during PCNL
- Excessive intra-operative bleeding
- Diabetes mellitus
- Coagulopathy
- Mental disorder
- ASA IV & V
- Active urinary tract infection.
Sites / Locations
- Armed Forces Institute of Urology.
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Local Anesthesia
Intravenous Analgesics
Arm Description
Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.
Group B patients received postoperative intravenous analgesia.
Outcomes
Primary Outcome Measures
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL.
Measurement: Postoperative pain Measurement tool: Visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT04835116
First Posted
March 28, 2021
Last Updated
April 10, 2021
Sponsor
Armed Forces Institute of Urology, Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT04835116
Brief Title
Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
Official Title
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Urology, Rawalpindi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
Detailed Description
The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain
Keywords
Local anesthesia, Percutaneous nephrolithotomy.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local Anesthesia
Arm Type
Other
Arm Description
Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.
Arm Title
Intravenous Analgesics
Arm Type
Other
Arm Description
Group B patients received postoperative intravenous analgesia.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
Other Intervention Name(s)
Local Anesthesia
Intervention Description
Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.
Intervention Type
Drug
Intervention Name(s)
paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
Other Intervention Name(s)
Intravenous analgesic
Intervention Description
Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required
Primary Outcome Measure Information:
Title
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Description
Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL.
Measurement: Postoperative pain Measurement tool: Visual analog scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients undergoing PCNL
age from 12-65 years
normal renal functions
no history of chronic pain
ASA I, II & III
Both genders
Exclusion Criteria:
history of local anaesthesia allergy
Redo PCNL
Multiple punctures during PCNL
Excessive intra-operative bleeding
Diabetes mellitus
Coagulopathy
Mental disorder
ASA IV & V
Active urinary tract infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musab Umair, MBBS
Organizational Affiliation
Armed Forces Institute of Urology.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Institute of Urology.
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
47040
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.
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