Peritubal Infiltration of Bupivacaine in PCNL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bupivacaine infiltration

10 ml of 0.25 % Bupivacaine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.

Normal saline infiltration

10 ml of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline infiltration

Intervention Type OTHER

23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin

Interventions

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Bupivacaine

23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.

Intervention Type DRUG

Normal saline infiltration

23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin

Intervention Type OTHER

Other Intervention Names

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normal saline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No