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Completed

NCT Number: NCT02801188

Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.

Mixture of bupivacaine and dexmedetomidine

Drug

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.