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Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones

Primary Purpose

Renal Stone

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine gel,
Naproxen Sodium
Lidocaine gel and Naproxen Sodium
Sponsored by
Shifa International Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring Lidocaine gel, Extracorporeal shockwave lithotripsy, Naproxen sodium, Pain score

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 to 70 years Having renal stone Meet the criteria for ESWL

Exclusion Criteria:

  • H/o chronic use of analgesia, 2) Allergy to any of the used medications, 3) those having ureteric stones, 4) Serum creatinine>1.4, 5) Pregnant patients, 6) having gastric ulcer disease, 7) not willing to participate, 8) Have coagulopathy and 9) active urinary-tract infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Lidocaine gel

    Naproxen Sodium

    Lidocaine Gel and Naproxen Sodium

    Arm Description

    20 grams Lidocaine gel 2 % will be applied to corresponding lumber area of the patients 30 minutes before undergoing ESWL for renal stone.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

    Oral Naproxen sodium 550 mg will given to patients 45 minutes before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

    Oral Naproxen sodium 55o mg and locally applied 2 % lidocaine gel to patients before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.

    Outcomes

    Primary Outcome Measures

    Mean pain score
    Pain score will be assessed immediately after completion of ESWL for those who will not need rescure intravenous analgesia and immediately just beforegiving rescue analgesia in those who needed it.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2016
    Last Updated
    May 26, 2016
    Sponsor
    Shifa International Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02786446
    Brief Title
    Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones
    Official Title
    Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones: A Randomized Control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shifa International Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination on the pain control during extracorporial shock wave lithotripsy for renal stones.
    Detailed Description
    Introduction of ESWL (extracorporeal shock wave lithotripsy) has revolutionized the treatment of urolithiasis due to its noninvasive in nature, cost effectiveness, reduced hospitalization time and less morbidity1, 2.Impact of shock waves cause pain in most of the patient requiring analgesia or sedation. It is important to make patient pain free to get the maximum possible stone free rates3, 4. Opioids are used most commonly for pain relief in ESWL but with side effects requiring patient monitoring and delayed hospital stay3, 4. NSAIDS also showed promising results regarding pain control in ESWL without side effects of opoids1, 5. Local analgesia gels have controversial role in relieving pain in ESWL 1, 6. There are yet no guidelines for pain relief during ESWL1, 4. We intend to compare the effect of local analgesia gel, oral NSAIDS and their combination on pain during lithotripsy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Stone
    Keywords
    Lidocaine gel, Extracorporeal shockwave lithotripsy, Naproxen sodium, Pain score

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    135 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine gel
    Arm Type
    Active Comparator
    Arm Description
    20 grams Lidocaine gel 2 % will be applied to corresponding lumber area of the patients 30 minutes before undergoing ESWL for renal stone.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.
    Arm Title
    Naproxen Sodium
    Arm Type
    Active Comparator
    Arm Description
    Oral Naproxen sodium 550 mg will given to patients 45 minutes before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.
    Arm Title
    Lidocaine Gel and Naproxen Sodium
    Arm Type
    Active Comparator
    Arm Description
    Oral Naproxen sodium 55o mg and locally applied 2 % lidocaine gel to patients before ESWL for renal stones.Max 4000 shockwaves will be administered. Rescue intravenous nalbuphine will be administered during procedure.Visual analogue pain score will be measured after completion of procedure or during procedure just before giving rescue iv analgesia if needed.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine gel,
    Other Intervention Name(s)
    Lignicaine
    Intervention Description
    2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
    Intervention Type
    Drug
    Intervention Name(s)
    Naproxen Sodium
    Other Intervention Name(s)
    NSAIDS
    Intervention Description
    Tab Naproxen sadium 550 mg per oral will be given to patients 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine gel and Naproxen Sodium
    Other Intervention Name(s)
    NSAIDS and Lidocaine
    Intervention Description
    Tab Naproxen sodium 550 mg per oral will be given to patients 45 minutes before ESWL and 2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
    Primary Outcome Measure Information:
    Title
    Mean pain score
    Description
    Pain score will be assessed immediately after completion of ESWL for those who will not need rescure intravenous analgesia and immediately just beforegiving rescue analgesia in those who needed it.
    Time Frame
    During or immediately after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 70 years Having renal stone Meet the criteria for ESWL Exclusion Criteria: H/o chronic use of analgesia, 2) Allergy to any of the used medications, 3) those having ureteric stones, 4) Serum creatinine>1.4, 5) Pregnant patients, 6) having gastric ulcer disease, 7) not willing to participate, 8) Have coagulopathy and 9) active urinary-tract infection.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones

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