- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02550782
Infraclavicular Perineural Dexmedetomidine
February 26, 2017 updated by: ILKE KUPELI, Cukurova University
Does Patient-Controlled Infraclavicular Perineural Dexmedetomidine Improve Postoperative Analgesia Deadline?
Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery.
Adjuvant agents are used in peripheral nerve blocks to increase the duration and block quality.
We investigated that the effects of patient-controlled perineural dexmedetomidine application on postoperative analgesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Erzincan, Merkez, Turkey, 24100
- Erzincan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be undergoing distal upper extremity surgery
- Be between 18-65 years
- to agree to participate in research
Exclusion Criteria:
- allergy to dexmedetomidine
- AV block or bradycardia
- being serious cardiac - liver - kidney function disorders
- Being coagulopathy
- neuropathy in the upper extremity
- adrenoceptor agonists or antagonists use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: perineural bupivacaine
patient-controlled infraclavicular perineural bupivacaine (1% bupivacaine (marcaine), 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) |
patient- controlled infraclavicular perineural marcaine infusion
patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion
|
|
Experimental: perineural dexmedetomidine
patient-controlled infraclavicular perineural dexmedetomidine (1% bupivacaine + 200 mic / 100cc dexmedetomidine, 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) |
patient- controlled infraclavicular perineural marcaine infusion
patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale
Time Frame: 3 month
|
Scores range from 0 [no pain] to 10 [worst possible pain
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
side effects
Time Frame: 3 month
|
3 month
|
|
The effect of dexmedetomidine to the Ramsey Sedation Scale
Time Frame: 3 month
|
3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.
- Latifzai K, Sites BD, Koval KJ. Orthopaedic anesthesia - part 2. Common techniques of regional anesthesia in orthopaedics. Bull NYU Hosp Jt Dis. 2008;66(4):306-16.
- Mariano ER, Loland VJ, Sandhu NS, Bishop ML, Lee DK, Schwartz AK, Girard PJ, Ferguson EJ, Ilfeld BM. Comparative efficacy of ultrasound-guided and stimulating popliteal-sciatic perineural catheters for postoperative analgesia. Can J Anaesth. 2010 Oct;57(10):919-26. doi: 10.1007/s12630-010-9364-7. Epub 2010 Aug 11.
- Gray AT, Collins AB, Schafhalter-Zoppoth I. An introduction to femoral nerve and associated lumbar plexus nerve blocks under ultrasonic guidance. Tech Reg Ananesth Pain Man. 2004;8:155-63.
- Greengrass R, Steele S, Moretti G. Peripheral nerve blocks. In: Raj PP, editor. Textbook of regional anesthesia. New York: Churchill Livingstone; 2002. p. 325-77.
- di Benedetto P, Casati A, Bertini L, Fanelli G, Chelly JE. Postoperative analgesia with continuous sciatic nerve block after foot surgery: a prospective, randomized comparison between the popliteal and subgluteal approaches. Anesth Analg. 2002 Apr;94(4):996-1000, table of contents. doi: 10.1097/00000539-200204000-00041.
- Svediene S, Andrijauskas A, Ivaskevicius J, Saikus A. The efficacy comparison of on-demand boluses with and without basal infusion of 0.1 % bupivacaine via perineural femoral catheter after arthroscopic ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):641-5. doi: 10.1007/s00167-012-1971-0. Epub 2012 Apr 13.
- Song JH, Shim HY, Lee TJ, Jung JK, Cha YD, Lee DI, Kim GW, Han JU. Comparison of dexmedetomidine and epinephrine as an adjuvant to 1% mepivacaine in brachial plexus block. Korean J Anesthesiol. 2014 Apr;66(4):283-9. doi: 10.4097/kjae.2014.66.4.283. Epub 2014 Apr 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
September 14, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Actual)
February 28, 2017
Last Update Submitted That Met QC Criteria
February 26, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Bupivacaine
Other Study ID Numbers
- Mengücek gazi
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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