Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

Fracture of Proximal Femur Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801188
• Other study ID #: MD / 128
• Status: Completed
• Phase: N/A
• Start date: October 1, 2014
• Est. completion date: December 1, 2015

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 1, 2015
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fracture of Proximal Femur
• Fractures, Bone

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain scores	The severity of pain will be assessed using a visual analog scale (VAS)	For 48 hours after surgery
Secondary	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
Secondary	Postoperative analgesic consumption	Total postoperative analgesic consumption	for 48 hours after surgery