Bier's Block Versus Systemic Analgesia

• ClinicalTrials.gov Identifier: NCT03349216
• Recruitment Status: Unknown
• First Posted: November 21, 2017
• Last Update Posted: November 21, 2017
• Sponsor: Isfahan University of Medical Sciences
• Information provided by (Responsible Party): Mehdi Nasr Isfahani, Isfahan University of Medical Sciences

Tracking Information

• First Submitted Date: November 11, 2017
• First Posted Date: November 21, 2017
• Last Update Posted Date: November 21, 2017
• Actual Study Start Date: October 20, 2017
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 16, 2017)

pain score [ Time Frame: 30 minutes since the beginning of procedure ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 16, 2017)

Complications [ Time Frame: 30 minutes ]

Seizure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Bier's Block with Lidocaine versus Conscous Sedation with ketamine

Masking: None (Open Label)
Masking Description:

not blinded

Primary Purpose: Treatment

• Condition: Distal Radius Fracture

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.
  Other Name: Bier's Block
• 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)
  Other Name: Conscious Sedation

Study Arms

• Experimental: Intravenous regional Analgesia
  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).
  Intervention: Procedure: Intravenous Regional Anesthesia
• Experimental: Systemic Analgesia
  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: Drug: Systemic Analgesia

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: November 16, 2017): 70
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: April 2018
• Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT03349216
• Other Study ID Numbers: 395608
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Mehdi Nasr Isfahani, Isfahan University of Medical Sciences
• Study Sponsor: Isfahan University of Medical Sciences
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mehdi Nasr Isfahani, M.D.; Isfahan University of Medical Sciences

• PRS Account: Isfahan University of Medical Sciences
• Verification Date: November 2017