Nerve Block, Intercostal NerveNCT01549405

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

A study testing İntercostal nerve block in people with Nerve Block, Intercostal Nerve, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Nerve Block, Intercostal Nerve
What is being tested?: İntercostal nerve block
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Feb 2012to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Derya Özkan
Ankara, 06110

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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).

Conditions: Nerve Block, Intercostal Nerve
Being tested: İntercostal nerve block
Keywords: percutanous nephrolitotomy,intercostal nerve block, Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01549405
Study group	Role	What they receive
Control group	No intervention	Control group: Group that without intercostal nerve block
nerve block	Experimental	Group that performing intercostal block Receives: Other: İntercostal nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Analgesic (Tramadol) Consumption
Total consumption of tramadol will be measured for the first 24 hours.
Measured: Postoperative 24th hour
Total Consumption of Tramadol Will be Measured for the First 24 Hours
Measured: Postoperative 24th hour

Secondary outcomes (1)

Postoperative Pain Will be Evaluated.
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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Aug 2012

First posted9 Mar 2012 (estimated)
Study startFeb 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Nerve Block, Intercostal NerveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01549405
Sponsor's protocol ID: Diskapi
Status last verified: Apr 2013
First submitted: 7 Mar 2012
Last updated: 2 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Recruiting
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
Breast Cancer, Postoperative Pain
Not yet recruiting
SPIP vs ESP Block in Cardiac Surgery
Cardiac Surgery, Chronic Postsurgical Pain
Not yet recruiting
Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery
Chronic Postoperative Pain, Chronic Post-Sternotomy Pain

All Nerve Block, Intercostal Nerve trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy
ClinicalTrials.gov ID: NCT01549405
Acronym / sponsor ID: Diskapi
Conditions: Nerve Block, Intercostal Nerve
Keywords: percutanous nephrolitotomy,intercostal nerve block, Ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Diskapi Teaching and Research HospitalUniversity, hospital or other
Study start: Feb 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 9 Mar 2012 (estimated)
Results: Posted 2 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control group	No intervention	–Control group: Group that without intercostal nerve block
nerve block	Experimental	Other: İntercostal nerve blockGroup that performing intercostal block

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
İntercostal nerve blockNerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.	Other	nerve block

Primary outcome

Postoperative Analgesic (Tramadol) Consumption
Time frame: Postoperative 24th hour
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

1 secondary outcome

Postoperative Pain Will be Evaluated.
Time frame: 24 hours

Results and safety

Results posted to the registry on 2 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	20	20
Nerve Block	20	20

Primary outcome: Postoperative Analgesic (Tramadol) Consumption

Time frame: Postoperative 24th hour

The sponsor has not posted figures for this outcome.

Primary outcome: Total Consumption of Tramadol Will be Measured for the First 24 Hours

Time frame: Postoperative 24th hour. Mean (Standard Deviation). Unit: mg

Measure	Control Group n = 20	Nerve Block n = 20
Value	199.7 (97.5)	77.6 (39.5)

Control Group vs Nerve Block: Mean Difference (Net): 122.1 (95% CI 52.98 to 132.4), p = 0.000, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 20 (0%)	0 of 20 (0%)	Not reported
İntercostal Nerve Block	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Nerve Block, Intercostal Nerve

RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Recruiting
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
Breast Cancer, Postoperative Pain
Not yet recruiting
SPIP vs ESP Block in Cardiac Surgery
Cardiac Surgery, Chronic Postsurgical Pain
Not yet recruiting
Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery
Chronic Postoperative Pain, Chronic Post-Sternotomy Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Derya Özkan, MD study director

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

Taylan Akkaya, MD principal investigator

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

Emine Arık, MD study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing İntercostal nerve block in people with Nerve Block, Intercostal Nerve, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Analgesic (Tramadol) Consumption (time frame: Postoperative 24th hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01549405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.