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

Not Applicable

Completed

• Conditions: Renal Stone
• Interventions: Drug: Lidocaine gel and Naproxen Sodium; Drug: Lidocaine gel,; Drug: Naproxen Sodium

• Registration Number: NCT02786446
• Lead Sponsor: Shifa International Hospital

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-05-26
• Last Update Submitted: 2016-05-26
• Study First Posted: 2016-06-01
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lidocaine Gel and Naproxen Sodium	Lidocaine gel and Naproxen Sodium	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.
Lidocaine gel	Lidocaine gel,	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.
Naproxen Sodium	Naproxen Sodium	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.

Primary Outcome Measures

Name	Time	Method
Mean pain score	During or immediately after procedure	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.