Pain Alleviation of Forearm Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine

Conditions
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Pain, Forearm Fracture

Intervention / Treatment
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* Drug: ketamine in hematoma block
* Drug: ketamine in local intravenous anesthesia
* Drug: Lidocaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine in hematoma block<br>Ketamine used in hematoma block | Drug: ketamine in hematoma block<br>* ketamine used in local hematoma block only<br>|
| Active Comparator: ketamine intravenous anesthesia<br>ketamine used in local intravenous anesthesia | Drug: ketamine in local intravenous anesthesia<br>* ketamine will be used with lidocaine in local intravenous anesthesia<br>|
| Active Comparator: lidocaine intravenous anesthesia<br>2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml. | Drug: Lidocaine Hydrochloride<br>* 2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessment | pain will be assessed by numerical rating scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia requirement | time of first analgesia requirement | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVRA, hematoma block