Bier's Block Versus Systemic Analgesia

Distal Radius Fracture Clinical Trial

Official title:

Comparison of Intravenous Regional Anesthesia ( Bier's Block) and Systemic Analgesia for Upper Extremity Procedures in the Emergency Department of Al-Zahra University Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03349216
• Other study ID #: 395608
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 11, 2017
• Last updated: November 16, 2017
• Start date: October 20, 2017
• Est. completion date: April 2018

Study information

• Verified date: November 2017
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: There are three methods for procedural sedation in upper extremity traumas; systemic, regional and local anesthesia. There is controversy in the literature regarding the method of choice for this purpose.

Objectives: The aim of this study was to compare conscious sedation and Bier's block methods for pain reduction in upper extremity trauma patients.

Patients and Methods: This was a randomized clinical trial. Patients were randomly allocated to either the Bier's block or the conscious sedation group. Pain reduction was assessed by a numerical rating scale; patients, surgeons and physicians responsible for analgesia satisfaction were assessed using a five-point Likert scale.

In this study, we aimed to compare the effectiveness, complications, duration, hemodynamic stability and patient and physician satisfaction between systemic analgesia and Bier's block method performed at the emergency department.

Description:

Patients and Methods

Study Design

This is a randomized clinical trial to be conducted at two tertiary health care centers, with census of 102000 and 60000 visits per year, during years 2017 and 2018. The study design has been approved by ethics committee of the university. Informed consents will be obtained from patients. And patients who refuse to participate in the study are excluded from the study and will receive analgesia based on the physician responsible for analgesia preference.

Population

All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia in the ED are included in this study. Patients with a history of seizure, known allergy to analgesic substances, sickle cell anemia, peripheral vascular disease and arteriovenous fistula or infection in upper extremities are excluded from the study. Patients who need emergent intervention/s that last more than one hour are also excluded from the study. Randomization is done using sealed envelopes containing computer-generated block random allocation numbers.

Intervention

After introduction of the protocol of Bier's block (using 1.5 mg/kg of 0.5% lidocaine) or systemic analgesia (using ketamine 1.5 mg/kg), patients underwent the necessary procedure. Physicians who were responsible for the analgesia, had authority to change the method of analgesia in each group, if necessary.

Measurements

Patient's age, sex, site and type of injury, vital signs and pain score using the Numerical Rating Scale (NRS) will be recorded before the introduction of analgesia. Patient's vital signs are documented at the end of the procedure. Satisfaction of the patient, surgeon and physician responsible for analgesia for the applied analgesic method is obtained before discharge from the ED operating room. Patients also score their level of pain before discharge and their vital signs are recorded at another instance. Time of initiation of analgesia, initiation of procedure, end of procedure, and gaining consciousness in systemic analgesia group and time of discharge from ED operating room are documented and patients will be discharged from the ED operating room when eligible.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• All adult patients (aged 18 or more) with upper extremity trauma who need procedural analgesia

Exclusion Criteria:

• Patients with a history of seizure

• Known allergy to analgesic substances

• Sickle cell anemia,

• Peripheral vascular disease and arteriovenous fistula

• Infection in upper extremities

• Patients who need emergent intervention/s that last more than one hour are also excluded from the study.

Related Conditions & MeSH terms

• Distal Radius Fracture
• Radius Fractures

Intervention

Procedure:
• Intravenous Regional Anesthesia
in this research patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes (A.T.S. 2000, Zimmer, Inc., Bloomfield, CN) will be deflated (hence named Rapid MiniBier's block). the pain score will be assessed by NRS system before during and after the procedure.

Drug:
• Systemic Analgesia
in this group the patients will receive ketamine 1-2 mg/kg IV slow ( Bioniche,Ireland Ketamine Hydrochloride 500mg/10cc)and titrated to effect. again here the pain score will be assessed before procedure and after the procedure every 5 minutes until 30 minutes by NRS ( Numerical Rating Score)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-Zahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	pain score assessed as numerical analogue score (NRS) with 1 for minimum and 10 for the maximum pain experienced by patient. A decrease of at least 13 millimeter will be considered as statistically meaningful.	30 minutes since the beginning of procedure
Secondary	Complications	Seizure	30 minutes