NCT01480102

Brief Summary

This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 14, 2019

Status Verified

March 1, 2019

Enrollment Period

9 years

First QC Date

November 23, 2011

Last Update Submit

March 13, 2019

Conditions

Post Operative Pain

Keywords

Percutaneous nephrolithotomyParavertebral blockbupivacaine

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    post-operative pain will be measured by the Visual Analog Scale (VAS.

    24 hours

Secondary Outcomes (1)

  • Opiod Use

    24 hours

Study Arms (2)

Group B- No Block

PLACEBO COMPARATOR

Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted.

Other: Group B- No block

Group A- Paravertebral block

ACTIVE COMPARATOR

Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space..

Drug: Group A-Paravertebral block

Interventions

Group A-Paravertebral blockDRUG

Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group

Also known as: Group A-Paravertebral block Active Group
Group A- Paravertebral block
Group B- No blockOTHER

direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.

Also known as: Placebo Group
Group B- No Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent to undergo percutaneous nephrolithotomy
  • Between the ages of 18 and 75
  • Able to consent, fill out study documents, and complete all study procedures and follow-up visits

You may not qualify if:

  • Will have bilateral percutaneous nephrolithotomy
  • Have an infection at the site of the proposed block
  • Have anatomy that prevents ability to perform block
  • Have a coagulopathy which may increase their chances of bleeding from the block
  • Have a known allergy to local anesthetics
  • Are unable to fill out the VAS scale due to physical or mental conditions
  • Are unable to use a patient controlled analgesia (PCA) device due to physical or mental conditions
  • Are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Thomas Turk

    Loyola Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2020

Study Completion

August 1, 2021

Last Updated

March 14, 2019

Record last verified: 2019-03

Locations

US(1)