NCT03048214

Brief Summary

This study aims to investigate whether infraclavicular nerve block improves acute postoperative pain after distal radial fracture surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

January 23, 2017

Last Update Submit

March 14, 2019

Conditions

Acute Pain

Keywords

Nerve block; Infraclavicular; Acute pain

Outcome Measures

Primary Outcomes (1)

  • Acute postoperative pain score

    pain score would be recorded on postoperative day 1 using numeral rating scale

    At postoperative day 1

Secondary Outcomes (2)

  • Chronic pain score

    At postoperative 3rd month

  • Analgesic drug consumption

    On discharge day

Study Arms (2)

General Anaesthesia

SHAM COMPARATOR

Patients would receive routine general anaesthesia for their distal radial fracture surgery

Procedure: General anaesthesia

Regional Anaesthesia

EXPERIMENTAL

Patients would receive routine infraclavicular nerve block for their distal radial fracture surgery

Procedure: Infraclavicular nerve block

Interventions

Infraclavicular nerve blockPROCEDURE

Infraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers.

Regional Anaesthesia
General anaesthesiaPROCEDURE

Usual practice for upper limb surgeries.

General Anaesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Age 18-80 years old
  • Scheduled for distal radial fracture surgery (ie open reduction and internal fixation)

You may not qualify if:

  • Surgery involving more than distal radial fracture of the affected arm
  • Known allergy to opioids (including the weak opioids tramadol and dihydrocodeine), local anaesthetic drugs, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors, paracetamol.
  • History of chronic pain
  • Alcohol or drug abuse
  • Impaired renal function, defined as preoperative serum creatinine level over 120 µmol/L
  • Patients with liver dysfunction (Plasma bilirubin over 34 mol/L, INR \>/=1.7, ALT and AST over 100U/L)
  • Pre-existing neurological or muscular disorders
  • Psychiatric illness
  • Impaired or retarded mental state
  • Not self-ambulatory before operation
  • Pregnancy
  • Local infection
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (3)

  • McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. doi: 10.1097/00000542-200408000-00028.

    PMID: 15277930BACKGROUND

  • Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3.

    PMID: 14499431BACKGROUND

  • Wong SS, Chan WS, Fang C, Chan CW, Lau TW, Leung F, Cheung CW. Infraclavicular nerve block reduces postoperative pain after distal radial fracture fixation: a randomized controlled trial. BMC Anesthesiol. 2020 May 28;20(1):130. doi: 10.1186/s12871-020-01044-4.

    PMID: 32466746DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Stanley SC Wong, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 9, 2017

Study Start

May 16, 2017

Primary Completion

July 13, 2018

Study Completion

December 14, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)