Peritubal Infiltration of Bupivacaine in PCNL

September 20, 2014 updated by: Zeeshan Arshad, Indus Hospital and Health Network

Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control

Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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
    • Sind
      • Karachi, Sind, Pakistan
        • Recruiting
        • The Indus Hospital
        • Principal Investigator:
          • Zeeshan Arshad, MBBS
        • Sub-Investigator:
          • Zafar Zaidi, MBBS

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-60 years of age
  • Single PCNL track

Exclusion Criteria:

  • Spinal Disc Prolapse
  • Any previous renal surgery

  • Complication secondary to PCNL

    • Hydrothorax that requires intervention
    • Pneumothorax
    • Massive hemorrhage that requires more than 1 U transfusion
    • Conversion to open procedure.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine infiltration
10 ml of 0.25 % Bupivacaine
Drug: Bupivacaine
23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.
Placebo Comparator: Normal saline infiltration
10 ml of normal saline
Other: Normal saline infiltration
23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean time for first demand of rescue analgesic
Time Frame: Release of the patient from the hospital or 24 hours (whichever comes first)
Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively
Release of the patient from the hospital or 24 hours (whichever comes first)

Collaborators and Investigators

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

Sponsor

Indus Hospital and Health Network

Investigators

  • Principal Investigator: Zeeshan Arshad, MBBS, The Indus Hospital
  • Study Director: Zafar Zaidi, MBBS, The Indus Hospital

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

July 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2014

Last Update Submitted That Met QC Criteria

September 20, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIH-Urology-001
  • IRD_IRB_2014_01_002 (Other Identifier: IRD IRB)

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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