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Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801188
Recruitment Status : Unknown
Verified June 2016 by Mansoura University.
Recruitment status was:  Recruiting
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
Fracture femur is a common that results in severe pain. Many methods of regional and peripheral analgesia have been described to treat such pain. In this study the investigators consider using paravertebral block to treat post-fracture pain. Additionally, they consider adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this block and hence postoperative analgesia.

Condition or disease Intervention/treatment Phase
Fracture of Proximal Femur Drug: Bupivacaine Drug: Mixture of bupivacaine and dexmedetomidine Not Applicable

Detailed Description:

Fracture femur is a common injury which is associated with excruciating pain . This pain is one of the most important causes of postoperative morbidity and mortality when it is insufficiently treated pain. Pain induces neuroendocrine stress response causing problems like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial ischemia and even infarction. These problems can be prevented by successful management of postoperative pain.

In patients with proximal femoral fracture, the use of paravertebral blockade produces reliable level of analgesia without need for additional nursing skills or monitoring in the postoperative period. Paravertebral blockade by injection local anesthetic solution alongside the vertebral column produces ipsilateral analgesia.

Currently available local anesthetics as bupivacaine may not provide reliable periods of analgesia resulting in block resolution before the period of worst postoperative pain. The use of a large volume of local anesthetic is one of methods to overcome this problem that may lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding adjuvants is another potential alternative.

Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the principle mechanism for the analgesic action of dexmedetomidine.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Placebo Comparator: Bupivacaine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
Drug: Bupivacaine
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.

Active Comparator: Mixture of bupivacaine and dexmedetomidine group
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine
Drug: Mixture of bupivacaine and dexmedetomidine
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine




Primary Outcome Measures :
  1. Scale for radiological spread of the injectate [ Time Frame: for 20 min after performing the blockade ]
    It will be assessed using the following scale -2; spread for two vertebral levels below the site of injection, -1; spread for one vertebral level below the site of injection, 0; stays at the level of injection, +2; spread for two vertebral levels above the site of injection, +1; spread for one vertebral level above the site of injection


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: For 48 hours after surgery ]
    The severity of pain will be assessed using a visual analog scale (VAS)

  2. Duration of postoperative analgesia [ Time Frame: for 24 hours after surgery ]
    The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded

  3. Postoperative analgesic consumption [ Time Frame: for 48 hours after surgery ]
    Total postoperative analgesic consumption



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical class I or II

Exclusion Criteria:

  • Patient refusal.
  • Severe or uncompensated cardiovascular disease.
  • Severe or uncompensated renal disease.
  • Severe or uncompensated hepatic disease.
  • Severe or uncompensated endocrinal disease.
  • Pregnancy.
  • Postpartum ladies.
  • Lactating females.
  • Allergy to any of the study medications .
  • Coagulation disorders.
  • Infection at the site of needle insertion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801188


Contacts
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Contact: Reem A El sharkawy, MD 00201006151100 reemraouf64@gmail.com
Contact: Mohamed Y Makharita, MD M_Younis24@yahoo.com

Locations
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Egypt
Mansoura university Recruiting
Mansoura, DK, Egypt, 050
Contact: Reem El sharkawy, MD    00201006151100    reemraouf64@gmail.com   
Sub-Investigator: Sherin A Bakrey, M.Sec         
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Reem A El sharkawy, MD Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Study Director: Mohamed Y Makharita, MD Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Study Chair: Nabil Abd-El Raouf, MD Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT02801188    
Other Study ID Numbers: MD ∕ 128
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Dexmedetomidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action