NCT03349216

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

November 11, 2017

Last Update Submit

November 16, 2017

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complications

    30 minutes

Study Arms (2)

Intravenous regional Analgesia

EXPERIMENTAL

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).

Procedure: Intravenous Regional Anesthesia

Systemic Analgesia

EXPERIMENTAL

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.

Drug: Systemic Analgesia

Interventions

Intravenous Regional AnesthesiaPROCEDURE

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.

Also known as: Bier's Block
Intravenous regional Analgesia
Systemic AnalgesiaDRUG

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)

Also known as: Conscious Sedation
Systemic Analgesia

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Zahra Hospital

Isfahan, 8713249877, Iran

Location

Related Publications (1)

  • Isfahani MN, Naseh K, Golshani K. Mini-dose Bier's block vs systemic analgesia in distal radius fractures: a promising reduction in emergency department throughput time. Pain Manag. 2023 Aug;13(8):433-443. doi: 10.2217/pmt-2023-0030. Epub 2023 Sep 18.

    PMID: 37718930DERIVED

MeSH Terms

Conditions

Wrist Fractures

Interventions

Conscious Sedation

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Mehdi Nasr Isfahani, M.D.

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
not blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Bier's Block with Lidocaine versus Conscous Sedation with ketamine
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 11, 2017

First Posted

November 21, 2017

Study Start

October 20, 2017

Primary Completion

January 1, 2018

Study Completion

April 1, 2018

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

IR(1)