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Bier's Block Versus Systemic Analgesia

Primary Purpose

Distal Radius Fracture

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intravenous Regional Anesthesia
Systemic Analgesia
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Al-Zahra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intravenous regional Analgesia

Systemic Analgesia

Arm Description

in this arm 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 will be deflated (hence named Rapid MiniBier's block).

In this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complications
Seizure

Full Information

First Posted
November 11, 2017
Last Updated
November 16, 2017
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03349216
Brief Title
Bier's Block Versus Systemic Analgesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Bier's Block with Lidocaine versus Conscous Sedation with ketamine
Masking
None (Open Label)
Masking Description
not blinded
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous regional Analgesia
Arm Type
Experimental
Arm Description
in this arm 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 will be deflated (hence named Rapid MiniBier's block).
Arm Title
Systemic Analgesia
Arm Type
Experimental
Arm Description
In this arm patients will receive ketamine 1-2 mg/kg IV slow as a systemic analgesia. ketamine as a PCP derivative has both hypnotic and analgesic effects.
Intervention Type
Procedure
Intervention Name(s)
Intravenous Regional Anesthesia
Other Intervention Name(s)
Bier's Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Systemic Analgesia
Other Intervention Name(s)
Conscious Sedation
Intervention Description
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)
Primary Outcome Measure Information:
Title
pain score
Description
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.
Time Frame
30 minutes since the beginning of procedure
Secondary Outcome Measure Information:
Title
Complications
Description
Seizure
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Nasr Isfahani, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Zahra Hospital
City
Isfahan
ZIP/Postal Code
8713249877
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bier's Block Versus Systemic Analgesia

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