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The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy

S

Saddam Al Demour

Status

Completed

Conditions

Renal Stone

Treatments

Drug: Marcaine Injectable Product

Study type

Interventional

Funder types

Other

Identifiers

NCT04160936
Sad2007

Details and patient eligibility

About

The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.

Full description

The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-70 years of age
  • body mass index <35,
  • renal stone size >2.0 cm.

Exclusion criteria

  • patients having supra-costal puncture.
  • excessive intraoperative bleeding.
  • renal stones requiring more than a single puncture.
  • surgical procedure extending more than 3 hours.
  • urinary tract infection.
  • severe cardiopulmonary disease.
  • abnormal renal function tests.
  • allergy to local anesthetics.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

study group :infiltration with 0.25% bupivacaine post-op
Active Comparator group
Description:
At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin
Treatment:
Drug: Marcaine Injectable Product
control group , no anesthesia infiltration post-op
No Intervention group
Description:
control group: no anesthesia infiltration had been given post opertatively

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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