Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?

Benha University

Status: Completed

Conditions: Blood Loss, Surgical

Treatments: Procedure: Nor-Epinephrine injection versus saline during PCNL

Study type: Interventional

Funder types: Other

Identifiers

NCT05035303

RC-200310

Details and patient eligibility

About

during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change & blood loss is estimated and will compared.

Full description

All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted.

nephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• renal stones>2 cm

Exclusion criteria

• coagulopathy, congenital anomalies, active Urinary tract infections

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Nor-Epinephrine (NE)-Group

Active Comparator group

Description:

The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.

Treatment:

Procedure: Nor-Epinephrine injection versus saline during PCNL

S-Group

Placebo Comparator group

Description:

The PCNL tract is infiltrated by Normal Saline before its dilatation.

Treatment:

Procedure: Nor-Epinephrine injection versus saline during PCNL