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Pain Alleviation of Forearm Fractures

Primary Purpose

Pain, Forearm Fracture

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ketamine in hematoma block
ketamine in local intravenous anesthesia
Lidocaine Hydrochloride
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring IVRA, hematoma block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients aged more than 18 years old.
  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation.
  • Patients scheduled for procedure lasting less than 90 minutes.

Exclusion Criteria:

  • Patients having cardiovascular co-morbidities.
  • Compound or contaminated fracture.
  • Peripheral vascular disease, sickle cell disease or coagulation disorders.
  • Allergy to the local anesthetics or to the drugs used in the study.

Sites / Locations

  • Faculty of Medicine, Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ketamine in hematoma block

ketamine intravenous anesthesia

lidocaine intravenous anesthesia

Arm Description

Ketamine used in hematoma block

ketamine used in local intravenous anesthesia

2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

Outcomes

Primary Outcome Measures

pain assessment
pain will be assessed by numerical rating scale

Secondary Outcome Measures

analgesia requirement
time of first analgesia requirement

Full Information

First Posted
December 12, 2017
Last Updated
February 26, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03377907
Brief Title
Pain Alleviation of Forearm Fractures
Official Title
Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
fractures of upper limb induce much pain . A lot of modalities are available to alleviate pain. fracture hematoma block, and intravenous regional anesthesia seem to be cost effective and attractive options
Detailed Description
Fractures of the forearm are extremely common, Pain relief is of utmost importance in forearm fractures which may need manipulation immediately for reduction followed by operative intervention The characteristic features of ideal analgesia during reduction are determined by safety, simplicity, affectivity and costs. Giventhe logistic difficulty of providing such anesthesia to such large number of patients simpler alternatives to conventional anesthesia have been tried. Hematoma Block alone, Hematoma Block with sedation, Bier's Block (Intravenous regional anesthesia), regional nerve blocks, sedation have been compared to general anesthesia to evaluate the efficacy, effectiveness, safety in treating such patients Amongst various techniques, HB and IVRA are attractive options. However, while HB has been demonstrated to be safe simple and has been used effectively for treatment of radius fractures in ER and for immediate pain relief it doesn't provide muscular relaxation and may not be sufficient for any operative intervention IVRA is suitable for operations of the distal extremities, in situations where it is safe and easy to apply an occlusive tourniquet. The primary advantages of IVRA are its simplicity, reliability, and cost-effectiveness. . It is a regional anesthetic technique that is easy to perform, with success rates varying between 94% and 98%.For these reasons, it remains a popular choice among anesthesiologists. A combination of blocks is usually done to overcome the deficiencies of individual blocks and to improve operating conditions or to prolong post operative analgesia. However the use of dual technique of IVRA and HB with local anesthetic only offered near absence of post operative analgesia Lidocaine is the most frequently used LA for IVRA and HB Different agents have been used as additive to local anesthetic for IVRA including phencyclidines, non-steroidal anti inflammatory drugs, opioids, and muscle relaxants. Ketamine is an effective anesthetic agent for IVRA at concentrations between 0.3% and 0.5%.it improves quality of anesthesia and peri operative analgesia without causing side effects Ketamine, a phenyl-piper dine derivative, was first synthesized in the early 1960 as an IV anesthetic agent. At sub anesthetic doses, ketamine exerts a noncompetitive blockade of N -methyl aspartate (NMDA) receptors. NMDA receptors play a major role in synaptic plasticity and are specifically implicated in central nervous system facilitation of pain processing. NMDA receptor antagonists have been implicated in perioperative pain management. Ketamine also has local anesthetic qualities, which have been studied as a sole agent for IVRA. In addition to spinal cord NMDA receptors, NMDA receptors have also been identified on peripheral unmyelinated sensory axons. This can explain why ketamine as an NMDA receptor antagonist was able to attenuate the tourniquet pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Forearm Fracture
Keywords
IVRA, hematoma block

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ketamine in hematoma block
Arm Type
Active Comparator
Arm Description
Ketamine used in hematoma block
Arm Title
ketamine intravenous anesthesia
Arm Type
Active Comparator
Arm Description
ketamine used in local intravenous anesthesia
Arm Title
lidocaine intravenous anesthesia
Arm Type
Active Comparator
Arm Description
2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
Intervention Type
Drug
Intervention Name(s)
ketamine in hematoma block
Intervention Description
ketamine used in local hematoma block only
Intervention Type
Drug
Intervention Name(s)
ketamine in local intravenous anesthesia
Intervention Description
ketamine will be used with lidocaine in local intravenous anesthesia
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Intervention Description
2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia
Primary Outcome Measure Information:
Title
pain assessment
Description
pain will be assessed by numerical rating scale
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
analgesia requirement
Description
time of first analgesia requirement
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients aged more than 18 years old. American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for closed fracture of distal upper extremity within 7 days, requiring open or closed reduction and internal fixation. Patients scheduled for procedure lasting less than 90 minutes. Exclusion Criteria: Patients having cardiovascular co-morbidities. Compound or contaminated fracture. Peripheral vascular disease, sickle cell disease or coagulation disorders. Allergy to the local anesthetics or to the drugs used in the study.
Facility Information:
Facility Name
Faculty of Medicine, Assiut University
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

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Pain Alleviation of Forearm Fractures

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