Peritubal Infiltration of Bupivacaine in PCNL

Indus Hospital and Health Network

Status and phase: Unknown; Phase 4

Conditions: Pain

Treatments: Drug: Bupivacaine; Other: Normal saline infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT02198027

TIH-Urology-001

IRD_IRB_2014_01_002 (Other Identifier)

Details and patient eligibility

About

Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-60 years of age
• Single PCNL track

Exclusion criteria

• Spinal Disc Prolapse

• Any previous renal surgery

• Complication secondary to PCNL

  • Hydrothorax that requires intervention
  • Pneumothorax
  • Massive hemorrhage that requires more than 1 U transfusion
  • Conversion to open procedure.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 2 patient groups, including a placebo group

Bupivacaine infiltration

Experimental group

Description:

10 ml of 0.25 % Bupivacaine

Treatment:

Drug: Bupivacaine

Normal saline infiltration

Placebo Comparator group

Description:

10 ml of normal saline

Treatment:

Other: Normal saline infiltration