Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

Study Overview
=================
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.

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.

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

Conditions
-----------------
Fracture of Proximal Femur

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Mixture of bupivacaine and dexmedetomidine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Bupivacaine group<br>Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye. | Drug: Bupivacaine<br>* Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.<br>|
| Active Comparator: Mixture of bupivacaine and dexmedetomidine group<br>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<br>* Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for radiological spread of the injectate | 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 | for 20 min after performing the blockade | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | The severity of pain will be assessed using a visual analog scale (VAS) | For 48 hours after surgery | 
| Duration of postoperative analgesia | The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded | for 24 hours after surgery | 
| Postoperative analgesic consumption | Total postoperative analgesic consumption | for 48 hours after surgery |