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

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Urolithiasis; Analgesia

Treatments: Drug: Xylocaine Gel; Drug: Ketorolac; Drug: Pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03032458

MD/16.11.72

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 3 patient groups

Pethidine

Active Comparator group

Description:

Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)

Treatment:

Drug: Pethidine

Ketorolac

Active Comparator group

Description:

Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)

Treatment:

Drug: Ketorolac

Xylocaine Gel

Active Comparator group

Description:

Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)

Treatment:

Drug: Xylocaine Gel