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Completed

NCT Number: NCT04835116

Comparison of Post-Operative 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.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Armed Forces Institute of Urology.

Rawalpindi, Punjab Province, 47040, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Armed Forces Institute of Urology, Rawalpindi

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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