Pain Alleviation of Forearm Fractures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377907
• Other study ID #: IRB17100203
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone
• Pain

Intervention

Drug:
• ketamine in hematoma block
ketamine used in local hematoma block only
• ketamine in local intravenous anesthesia
ketamine will be used with lidocaine in local intravenous anesthesia
• Lidocaine Hydrochloride
2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assessment	pain will be assessed by numerical rating scale	24 hours
Secondary	analgesia requirement	time of first analgesia requirement	24 hours