Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01549405
First received: March 7, 2012
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Nerve Block, Intercostal Nerve
Other: İntercostal nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • Postoperative Analgesic (Tramadol) Consumption [ Time Frame: Postoperative 24th hour ] [ Designated as safety issue: Yes ]
    Total consumption of tramadol will be measured for the first 24 hours.

  • Total Consumption of Tramadol Will be Measured for the First 24 Hours [ Time Frame: Postoperative 24th hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative Pain Will be Evaluated. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.("0" no pain, to "10", the maximum pain )Pain score less then 4 is acceptable.


Enrollment: 40
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Control group: Group that without intercostal nerve block
Experimental: nerve block
Group that performing intercostal block
Other: İntercostal nerve block
Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.

Detailed Description:

Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Respiratory or cardiac disfunction
  • Neuropathy
  • Coagulopathy
  • BMI (Body mass index)over 30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549405

Locations
Turkey
Derya Özkan
Ankara, Turkey, 06110
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Study Director: Derya Özkan, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Principal Investigator: Taylan Akkaya, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Study Chair: 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
  More Information

No publications provided

Responsible Party: derya özkan, Consultant of Anesthesiology ,MD, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01549405     History of Changes
Other Study ID Numbers: Diskapi
Study First Received: March 7, 2012
Results First Received: February 21, 2013
Last Updated: April 1, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Diskapi Teaching and Research Hospital:
percutanous nephrolitotomy,intercostal nerve block, Ultrasound

ClinicalTrials.gov processed this record on October 29, 2014