Clinical trial NCT03032458: Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy
Official title: Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Urolithiasis
Keywords: Shock Wave Lithotripsy
Ketorolac
Xylocaine Gel
Pethidine
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 165
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"
timeFrame: 10 months
Secondary outcomes:
measure: Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "
timeFrame: 10 months
measure: Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"
timeFrame: 10 months
measure: Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and Nephrology Center
name: Hassan Abol-Enein, MD, Phd
role: STUDY_CHAIR
References: