Pain Alleviation of Forearm Fractures

NCT ID: NCT03377907

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-12-01

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.

Conditions

Pain; Forearm Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ketamine in hematoma block

Ketamine used in hematoma block

Group Type: ACTIVE_COMPARATOR

ketamine in hematoma block

Intervention Type: DRUG

ketamine used in local hematoma block only

ketamine intravenous anesthesia

ketamine used in local intravenous anesthesia

Group Type: ACTIVE_COMPARATOR

ketamine in local intravenous anesthesia

Intervention Type: DRUG

ketamine will be used with lidocaine in local intravenous anesthesia

lidocaine intravenous anesthesia

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

Group Type: ACTIVE_COMPARATOR

Lidocaine Hydrochloride

Intervention Type: DRUG

2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia

Interventions

ketamine in hematoma block

ketamine used in local hematoma block only

Intervention Type: DRUG

ketamine in local intravenous anesthesia

ketamine will be used with lidocaine in local intravenous anesthesia

Intervention Type: DRUG

Lidocaine Hydrochloride

2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed mamdouh mohammed mahmoud

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

IRB17100203

Identifier Type: -

Identifier Source: org_study_id