Clinical trial NCT03349216: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Distal Radius Fracture
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bier's Block with Lidocaine versus Conscous Sedation with ketamine
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: pain score
timeFrame: 30 minutes since the beginning of procedure
Secondary outcomes:
measure: Complications
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-Zahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mehdi Nasr Isfahani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: