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Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

Primary Purpose

Fracture of Proximal Femur

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Mixture of bupivacaine and dexmedetomidine
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fracture of Proximal Femur

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Bupivacaine group

Mixture of bupivacaine and dexmedetomidine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain scores
The severity of pain will be assessed using a visual analog scale (VAS)
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
Postoperative analgesic consumption
Total postoperative analgesic consumption

Full Information

First Posted
April 22, 2016
Last Updated
September 19, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02801188
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Proximal Femur

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine group
Arm Type
Placebo Comparator
Arm Description
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
Arm Title
Mixture of bupivacaine and dexmedetomidine group
Arm Type
Active Comparator
Arm Description
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye and 1 ug/kg of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
Intervention Type
Drug
Intervention Name(s)
Mixture of bupivacaine and dexmedetomidine
Intervention Description
Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
Primary Outcome Measure Information:
Title
Scale for radiological spread of the injectate
Description
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
Time Frame
for 20 min after performing the blockade
Secondary Outcome Measure Information:
Title
Pain scores
Description
The severity of pain will be assessed using a visual analog scale (VAS)
Time Frame
For 48 hours after surgery
Title
Duration of postoperative analgesia
Description
The period from completion of the block to time of administration of the first request of rescue analgesic for postoperative pain will be recorded
Time Frame
for 24 hours after surgery
Title
Postoperative analgesic consumption
Description
Total postoperative analgesic consumption
Time Frame
for 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem A El sharkawy, MD
Organizational Affiliation
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Y Makharita, MD
Organizational Affiliation
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nabil Abd-El Raouf, MD
Organizational Affiliation
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura university
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block

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