NCT01549405

Brief Summary

Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 2, 2013

Completed
Last Updated

April 2, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

March 7, 2012

Results QC Date

February 21, 2013

Last Update Submit

April 1, 2013

Conditions

Keywords

percutanous nephrolitotomy,intercostal nerve block, Ultrasound

Outcome Measures

Primary Outcomes (2)

  • Postoperative Analgesic (Tramadol) Consumption

    Total consumption of tramadol will be measured for the first 24 hours.

    Postoperative 24th hour

  • Total Consumption of Tramadol Will be Measured for the First 24 Hours

    Postoperative 24th hour

Secondary Outcomes (1)

  • Postoperative Pain Will be Evaluated.

    24 hours

Study Arms (2)

Control group

NO INTERVENTION

Control group: Group that without intercostal nerve block

nerve block

EXPERIMENTAL

Group that performing intercostal block

Other: İntercostal nerve block

Interventions

Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.

nerve block

Eligibility Criteria

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

You may qualify if:

  • Patients admitted for the removal of renal stones by percutaneous
  • nephrolithotomy (PCNL)
  • ASA I-II status

You may not qualify if:

  • Respiratory or cardiac disfunction
  • Neuropathy
  • Coagulopathy
  • BMI (Body mass index)over 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derya Özkan

Ankara, 06110, Turkey (Türkiye)

Location

Results Point of Contact

Title
Dr Derya Özkan
Organization
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital

Study Officials

  • Derya Özkan, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    STUDY DIRECTOR
  • Taylan Akkaya, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    PRINCIPAL INVESTIGATOR
  • Emine Arık, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    STUDY CHAIR
  • Zeynep Koç, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    STUDY CHAIR
  • Nihat Karakoyunlu, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic

    STUDY CHAIR
  • Haluk Gümüs, MD

    1Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    STUDY CHAIR
  • Hamit Ersoy, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic

    STUDY CHAIR
  • Julide Ergil, MD

    Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Anesthesiology ,MD

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

April 2, 2013

Results First Posted

April 2, 2013

Record last verified: 2013-04

Locations