NCT03913650

Brief Summary

To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

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

May 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

September 17, 2017

Last Update Submit

February 15, 2020

Conditions

Pain, PostoperativeChange; CirculatorySurgical Injury

Keywords

peripheral nerve blockIL-6post-operative painlimb surgery

Outcome Measures

Primary Outcomes (1)

  • peak pain intensity in the postoperative care unit

    pain score evaluated by pain score

    2 hours

Secondary Outcomes (1)

  • change of perioperative IL-6 level

    up to 6 hours

Other Outcomes (2)

  • changes of perioperative hemodynamic parameter

    up to 3 hours

  • changes of perioperative hemodynamic parameter

    up to 3 hours

Study Arms (2)

Nerve block(+)

ACTIVE COMPARATOR

patient accept nerve block for post-op pain control

Procedure: 0.25% bupivacaine

Morphine

SHAM COMPARATOR

patient received morphine for post-op pain control

Procedure: 0.25% bupivacaine

Interventions

0.25% bupivacainePROCEDURE

nerve block procedure will be decided by patients' will for post-op pain

Also known as: nerve block with 0.25% bupivacaine
MorphineNerve block(+)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of limb fracture
  • must receiving orthopedic surgery

You may not qualify if:

  • With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

I-Cheng Lu

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, 812, Taiwan

Location

MeSH Terms

Conditions

Pain, PostoperativeIntraoperative Complications

Interventions

BupivacaineNerve Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • I-Cheng Lu, MD, PHD

    Kaohsiung Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting staff

Study Record Dates

First Submitted

September 17, 2017

First Posted

April 12, 2019

Study Start

May 15, 2017

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

TW(2)