Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

April 10, 2021 updated by: Musab Umair Khalid, Armed Forces Institute of Urology, Rawalpindi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 47040
        • Armed Forces Institute of Urology.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Local Anesthesia
Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.
Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
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.
Other Names:
  • Local Anesthesia
Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
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
Other Names:
  • Intravenous analgesic
OTHER: Intravenous Analgesics
Group B patients received postoperative intravenous analgesia.
Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.
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.
Other Names:
  • Local Anesthesia
Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.
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
Other Names:
  • Intravenous analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Urology, Rawalpindi

Investigators

  • Principal Investigator: Musab Umair, MBBS, Armed Forces Institute of Urology.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2019

Primary Completion (ACTUAL)

October 11, 2019

Study Completion (ACTUAL)

October 11, 2019

Study Registration Dates

First Submitted

March 28, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 10, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFIU Rawalpindi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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