Clinical trial NCT02801188: Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block
Official title: Evaluation Effect of Adding Dexmedetomidine to Bupivacaine for Paravertebral Block in Femoral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture of Proximal Femur
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Scale for radiological spread of the injectate
timeFrame: for 20 min after performing the blockade
Secondary outcomes:
measure: Pain scores
timeFrame: For 48 hours after surgery
measure: Duration of postoperative analgesia
timeFrame: for 24 hours after surgery
measure: Postoperative analgesic consumption
timeFrame: for 48 hours after surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: DK
Study officials:
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Reem A El sharkawy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Mohamed Y Makharita, MD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Nabil Abd-El Raouf, MD
role: STUDY_CHAIR
References: