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

Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones: A Randomized Control Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02786446
Enrollment
135
Registered
2016-06-01
Start date
2015-07-31
Completion date
2016-01-31
Last updated
2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stone

Keywords

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

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.

Interventions

DRUGLidocaine gel,

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.

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.

DRUGLidocaine gel and Naproxen Sodium

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.

Sponsors

Shifa International Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean pain scoreDuring or immediately after procedurePain 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026