The Analgesic EffectsNCT02550782
Infraclavicular Perineural Dexmedetomidine
A study testing Bupivacaine and Dexmedetomidine in people with The Analgesic Effects, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- The Analgesic Effects
- What is being tested?
- Bupivacaine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- be undergoing distal upper extremity surgery
- Be between 18-65 years
- to agree to participate in research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- The Analgesic Effects
- Being tested
- Bupivacaine, Dexmedetomidine
- Keywords
- perineural dexmedetomidine, infraclavicular perineural catheter, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
patient- controlled infraclavicular perineural marcaine infusion
DexmedetomidineDrug
patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion
| Study group | Role | What they receive |
|---|---|---|
| perineural bupivacaine | Active comparator | patient-controlled infraclavicular perineural bupivacaine
(1% bupivacaine (marcaine), 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) Receives: Drug: Bupivacaine; Drug: Dexmedetomidine |
| perineural dexmedetomidine | Experimental | 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) Receives: Drug: Bupivacaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Scores range from 0 [no pain] to 10 [worst possible pain
Measured: 3 month
Secondary outcomes (2)
side effects
Measured: 3 month
The effect of dexmedetomidine to the Ramsey Sedation Scale
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for The Analgesic EffectsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzincan University
- Responsible party
- Principal investigator, ILKE KUPELI, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550782
- Sponsor's protocol ID
- Mengücek gazi
- Status last verified
- Feb 2017
- First submitted
- 14 Sep 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19093908Mariano 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.
PubMed 20700680Gray 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.
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.
PubMed 14570643di 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.
PubMed 11916811Svediene 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.
PubMed 22527409Song 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.
PubMed 24851163
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Patient-Controlled Infraclavicular Perineural Dexmedetomidine Improve Postoperative Analgesia Deadline?
- ClinicalTrials.gov ID
- NCT02550782
- Acronym / sponsor ID
- Mengücek gazi
- Conditions
- The Analgesic Effects
- Keywords
- perineural dexmedetomidine, infraclavicular perineural catheter, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Erzincan University
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineural bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Dexmedetomidinepatient-controlled infraclavicular perineural bupivacaine (1% bupivacaine (marcaine), 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) |
| perineural dexmedetomidine | Experimental | Drug: Bupivacaine, Drug: Dexmedetomidinepatient-controlled infraclavicular perineural dexmedetomidine (1% bupivacaine + 200 mic / 100cc dexmedetomidine, 5 ml bolus dose, infusion rate of 5 ml / h, lockout time 1 hour) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be undergoing distal upper extremity surgery
- Be between 18-65 years
- to agree to participate in research
Key exclusion criteria (6 listed)
- allergy to dexmedetomidine
- AV block or bradycardia
- being serious cardiac - liver - kidney function disorders
- Being coagulopathy
- neuropathy in the upper extremity
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 |
|---|---|---|
| Bupivacainepatient- controlled infraclavicular perineural marcaine infusion | Drug | perineural bupivacaine, perineural dexmedetomidine |
| Dexmedetomidinepatient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion | Drug | perineural bupivacaine, perineural dexmedetomidine |
Primary outcome
visual analog scale
Time frame: 3 month
Scores range from 0 [no pain] to 10 [worst possible pain
2 secondary outcomes
side effects
Time frame: 3 month
The effect of dexmedetomidine to the Ramsey Sedation Scale
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Background: PubMed 19093908Latifzai 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.
- Background: PubMed 20700680Mariano 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.
- BackgroundGray 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.
- BackgroundGreengrass R, Steele S, Moretti G. Peripheral nerve blocks. In: Raj PP, editor. Textbook of regional anesthesia. New York: Churchill Livingstone; 2002. p. 325-77.
- Background: PubMed 14570643White 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.
- Background: PubMed 11916811di 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.
- Results publication: PubMed 22527409Svediene 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.
- Results publication: PubMed 24851163Song 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Dexmedetomidine in people with The Analgesic Effects, run by Cukurova University 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 6 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 28 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analog scale (time frame: 3 month). 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 NCT02550782, which also lists 8 linked publications.
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 28 Feb 2017.