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Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy

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ClinicalTrials.gov Identifier: NCT03032458
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelwahab Hashem, Mansoura University

Brief Summary:
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.

Condition or disease Intervention/treatment Phase
Analgesia Urolithiasis Drug: Pethidine Drug: Ketorolac Drug: Xylocaine Gel Phase 4

Detailed Description:

Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.

Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.

Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.

Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.

In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.

The investigators will try in this trial to identify the best efficacious type of analgesia for patient during SWL in this study.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pethidine
Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
Drug: Pethidine
pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg
Other Name: Pethidine 50

Active Comparator: Ketorolac
Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
Drug: Ketorolac
ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.
Other Name: Ketolac

Active Comparator: Xylocaine Gel
Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
Drug: Xylocaine Gel
Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
Other Name: lidocaine 2%




Primary Outcome Measures :
  1. Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)" [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item " [ Time Frame: 10 months ]
  2. Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)" [ Time Frame: 10 months ]
  3. Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan. [ Time Frame: 1 year ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with renal and upper ureteral stones amenable to SWL.

Exclusion Criteria:

  • Allergy to pethidine.
  • Allergy to Ketorolac.
  • Allergy to Xylocaine gel.
  • American Society of Anesthesiologists score ≥ 3 (ASA III or more).
  • Pregnancy.
  • Patients with a pacemaker.
  • Bleeding diatheses.
  • Uncontrolled urinary tract infection (UTI).
  • Severe obesity which prevent targeting of the stone.
  • Body Mass IndexBMI (40 or more)
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032458


Locations
Egypt
Urology and Nephrology Center
Mansourah, Aldakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
Study Chair: Hassan Abol-Enein, MD, Phd Urology and Nephrology Center

Responsible Party: Abdelwahab Hashem, Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03032458     History of Changes
Other Study ID Numbers: MD/16.11.72
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)

Keywords provided by Abdelwahab Hashem, Mansoura University:
Shock Wave Lithotripsy
Ketorolac
Xylocaine Gel
Pethidine

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Urolithiasis
Urologic Diseases
Lidocaine
Meperidine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia