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Clinical Trials/NCT04835116
NCT04835116
Completed
Phase 4

Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.

Armed Forces Institute of Urology, Rawalpindi1 site in 1 country68 target enrollmentApril 11, 2019

Overview

Phase
Phase 4
Intervention
Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
Conditions
Pain
Sponsor
Armed Forces Institute of Urology, Rawalpindi
Enrollment
68
Locations
1
Primary Endpoint
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2019
End Date
October 11, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Armed Forces Institute of Urology, Rawalpindi
Responsible Party
Principal Investigator
Principal Investigator

Musab Umair Khalid

Doctor

Armed Forces Institute of Urology, Rawalpindi

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.

Arms & Interventions

Local Anesthesia

Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.

Intervention: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.

Local Anesthesia

Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.

Intervention: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Intravenous Analgesics

Group B patients received postoperative intravenous analgesia.

Intervention: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.

Intravenous Analgesics

Group B patients received postoperative intravenous analgesia.

Intervention: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Outcomes

Primary Outcomes

Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.

Time Frame: 6 months

Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL. Measurement: Postoperative pain Measurement tool: Visual analog scale

Study Sites (1)

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