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

NCT02786446 | Completed

• 1 other identifier: ShifaIH
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Stone

Keywords

Lidocaine gel; Extracorporeal shockwave lithotripsy; Naproxen sodium; Pain score

Outcome Measures

Primary Outcomes (1)

• Mean pain score

  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.

  During or immediately after procedure

Study Arms (3)

Lidocaine gel

ACTIVE COMPARATOR

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.

Drug: Lidocaine gel,

Naproxen Sodium

ACTIVE COMPARATOR

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.

Drug: Naproxen Sodium

Lidocaine Gel and Naproxen Sodium

ACTIVE COMPARATOR

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.

Drug: Lidocaine gel and Naproxen Sodium

Interventions

Lidocaine gel, DRUG

2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Also known as: Lignicaine

Lidocaine gel

Naproxen Sodium DRUG

Tab Naproxen sadium 550 mg per oral will be given to patients 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Also known as: NSAIDS

Naproxen Sodium

Lidocaine gel and Naproxen Sodium DRUG

Tab Naproxen sodium 550 mg per oral will be given to patients 45 minutes before ESWL and 2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.

Also known as: NSAIDS and Lidocaine

Lidocaine Gel and Naproxen Sodium

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years Having renal stone Meet the criteria for ESWL

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shifa International Hospital: lead

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Lidocaine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Trainee

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 1, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share