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Pain Alleviation of Forearm Fractures

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ClinicalTrials.gov Identifier: NCT03377907
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed mamdouh mohammed mahmoud, Assiut University

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2017)
pain assessment [ Time Frame: 24 hours ]
pain will be assessed by numerical rating scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2017)
analgesia requirement [ Time Frame: 24 hours ]
time of first analgesia requirement
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Alleviation of Forearm Fractures
Official Title  ICMJE Perioperative Pain Alleviation of Forearm Fractures Using a Combination of Hematoma Block and Intravenous Regional Anesthesia by Ketamine and Lidocaine
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Forearm Fracture
Intervention  ICMJE
  • Drug: ketamine in hematoma block
    ketamine used in local hematoma block only
  • Drug: ketamine in local intravenous anesthesia
    ketamine will be used with lidocaine in local intravenous anesthesia
  • Drug: Lidocaine Hydrochloride
    2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia
Study Arms  ICMJE
  • Active Comparator: Ketamine in hematoma block
    Ketamine used in hematoma block
    Intervention: Drug: ketamine in hematoma block
  • Active Comparator: ketamine intravenous anesthesia
    ketamine used in local intravenous anesthesia
    Intervention: Drug: ketamine in local intravenous anesthesia
  • Active Comparator: lidocaine intravenous anesthesia
    2.5 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
    Intervention: Drug: Lidocaine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
66
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2017)
50
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377907
Other Study ID Numbers  ICMJE IRB17100203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohammed mamdouh mohammed mahmoud, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP