Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

Mansoura University

Status: Completed

Conditions: Fracture of Proximal Femur

Treatments: Drug: Bupivacaine; Drug: Mixture of bupivacaine and dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02801188

MD ∕ 128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Bupivacaine group

Placebo Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Mixture of bupivacaine and dexmedetomidine group

Active Comparator group

Description:

Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine

Treatment:

Drug: Mixture of bupivacaine and dexmedetomidine