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

NCT ID: NCT03032458

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-10-31

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.

Conditions

Analgesia; Urolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pethidine

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

Group Type: ACTIVE_COMPARATOR

Pethidine

Intervention Type: DRUG

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

Ketorolac

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

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

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.

Xylocaine Gel

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

Group Type: ACTIVE_COMPARATOR

Xylocaine Gel

Intervention Type: DRUG

Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then

Interventions

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Pethidine 50; Ketolac; lidocaine 2%

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Abol-Enein, MD, Phd

Role: STUDY_CHAIR

Urology and Nephrology Center

Locations

Urology and Nephrology Center

Al Mansurah, Aldakahlia, Egypt

Countries

Egypt

Other Identifiers

MD/16.11.72

Identifier Type: -

Identifier Source: org_study_id