NCT02550782

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

September 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

September 14, 2015

Last Update Submit

February 26, 2017

Conditions

The Analgesic Effects

Keywords

perineural dexmedetomidineinfraclavicular perineural catheterpostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    Scores range from 0 \[no pain\] to 10 \[worst possible pain

    3 month

Secondary Outcomes (2)

  • side effects

    3 month

  • The effect of dexmedetomidine to the Ramsey Sedation Scale

    3 month

Study Arms (2)

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)

Drug: BupivacaineDrug: 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)

Drug: BupivacaineDrug: Dexmedetomidine

Interventions

BupivacaineDRUG

patient- controlled infraclavicular perineural marcaine infusion

perineural bupivacaineperineural dexmedetomidine
DexmedetomidineDRUG

patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion

perineural bupivacaineperineural dexmedetomidine

Eligibility Criteria

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

You may qualify if:

  • be undergoing distal upper extremity surgery
  • Be between 18-65 years
  • to agree to participate in research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Üniversity

Erzincan, Merkez, 24100, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 19093908BACKGROUND

  • 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.

    PMID: 20700680BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 14570643BACKGROUND

  • 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.

    PMID: 11916811BACKGROUND

  • 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.

    PMID: 22527409RESULT

  • 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.

    PMID: 24851163RESULT

MeSH Terms

Interventions

BupivacaineDexmedetomidine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthesiology and reanimation

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

TU(1)