Peritubal Infiltration of Bupivacaine in PCNL

Phase 4

• Conditions: Pain
• Interventions: Other: Normal saline infiltration; Drug: Bupivacaine

• Registration Number: NCT02198027
• Lead Sponsor: Indus Hospital and Health Network

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-20
• Last Update Posted: 2014-09-23
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline infiltration	Normal saline infiltration	10 ml of normal saline
Bupivacaine infiltration	Bupivacaine	10 ml of 0.25 % Bupivacaine

Primary Outcome Measures

Name	Time	Method
Mean time for first demand of rescue analgesic	Release of the patient from the hospital or 24 hours (whichever comes first)	Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively

Trial Locations

Locations (1)

The Indus Hospital; 🇵🇰 Karachi, Sind, Pakistan