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

S

Shifa International Hospital

Status

Completed

Conditions

Renal Stone

Treatments

Drug: Naproxen Sodium
Drug: Lidocaine gel and Naproxen Sodium
Drug: Lidocaine gel,

Study type

Interventional

Funder types

Other

Identifiers

NCT02786446
ShifaIH

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

135 participants in 3 patient groups

Lidocaine gel
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine gel,
Naproxen Sodium
Active Comparator group
Description:
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.
Treatment:
Drug: Naproxen Sodium
Lidocaine Gel and Naproxen Sodium
Active Comparator group
Description:
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.
Treatment:
Drug: Lidocaine gel and Naproxen Sodium

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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