NCT02125565

Brief Summary

Arterial Blood Gas (ABG) sampling is a common procedure in all hospitals worldwide. Often, ABG samples are obtain from inserting a needle into the radial artery at the wrist - this procedure is often painful and dreaded by patients. Therefore, some doctors use local anaesthetic but others argue that it makes the procedure more difficult and causes pain itself. The use of local anaesthetic costs approximately £1 per injection and when thousands of ABGs are performed per month, the cost is easily appreciable. However, there is no good research to guide clinicians in the use or omission of local anaesthetic for ABGs. This is the first randomised clinical trial to assess the efficacy of injected local anaesthetic on the perceived pain of radial artery puncture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

April 25, 2014

Last Update Submit

April 29, 2014

Conditions

Vascular Access

Keywords

ArterialBloodGasNeedlePainLocalAnaesthesiaAnaesthetic

Outcome Measures

Primary Outcomes (1)

  • Pain

    Our primary outcome was pain experienced by patients during radial artery puncture, reported on a 10 cm Visual Analogue Scale (VAS). A VAS allows accurate pain assessment (being able to differentiate up to 1 mm or 1%) and does not limit responses unlike a Likert scale.

    Immediate

Secondary Outcomes (8)

  • Quality of Pulse

    Immediate

  • Use of systemic analgesia

    Immediate

  • Need guage for local anaesthesia

    Immediate

  • Needle gauge for ABG acquisition

    Immediate

  • Movement during ABG acquisition

    Immediate

  • +3 more secondary outcomes

Study Arms (2)

Local Anaesthesia

EXPERIMENTAL

These subjects received an injection of lidocaine 1% 2ml subcutaneously prior to arterial puncture

Other: Injected subcutaneous local (lidocaine) anaesthesia

No Local Anaesthesia

NO INTERVENTION

Patients underwent arterial puncture directly with NO prior anaesthesia

Interventions

Injected subcutaneous local (lidocaine) anaesthesiaOTHER

Trial of technique

Local Anaesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients meeting any of the below criteria will be excluded:
  • Negative Allen's test - patients with no clinically visible connection between the radial and ulnar arteries will be excluded, as compromise of the radial artery through puncture and thrombosis may theoretically result in hand ischaemia.
  • Urgent ABG - patients requiring an urgent ABG (within 20 minutes) will be unable to fully consider the participant information sheet and consent, so will be excluded.
  • GCS \<15 - patients who are not fully alert and orientated will be excluded as they cannot consent to participate and altered conscious levels may affect pain perception.
  • Prior failed ABG attempt on the contralateral limb.
  • Previous participation - this will be ascertained from the Trial folder (participants will have their JPUH Patient ID recorded).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Paget University Hospitals NHS Foundation Trust

Gorelston, Norfolk, NR31 6LA, United Kingdom

Location

Related Publications (1)

  • Wade RG, Crawfurd J, Wade D, Holland R. Radial artery blood gas sampling: a randomized controlled trial of lidocaine local anesthesia. J Evid Based Med. 2015 Nov;8(4):185-91. doi: 10.1111/jebm.12177.

    PMID: 26779697DERIVED

MeSH Terms

Conditions

Mucopolysaccharidosis IVPain

Interventions

LidocaineAnesthesia

Condition Hierarchy (Ancestors)

MucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia and Analgesia

Study Officials

  • Ryckie G Wade, MBBS MClinEd MRCS FHEA

    James Paget Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Core Surgical Trainee

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

December 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

GB(1)