The Influence of Peripheral Nerve Blocks in Patients Unde... | NCT03913650

Studies
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery

NCT03913650

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Completed

Last Update Posted

Feb 18, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pain, Postoperative
Change; Circulatory
Surgical Injury

Interventions

0.25% bupivacaine

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2017Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Sep 17, 2017

First Submission Date that Met QC Criteria

Apr 11, 2019

First Posted Date

Apr 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2020

Last Update Posted Date

Feb 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

I-Cheng Lu, Visiting staff, Kaohsiung Medical University Chung-Ho Memorial HospitalPrincipal Investigator

Lead Sponsor

Kaohsiung Medical University Chung-Ho Memorial HospitalOTHER

Collaborators

Name	Class
Kaohsiung Municipal Hsiaokang Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
0.25% bupivacaine	Procedure	nerve block procedure will be decided by patients' will for post-op pain	Morphine Nerve block(+)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak pain intensity in the postoperative care unit	pain score evaluated by pain score	2 hours

Secondary Outcomes

Measure	Description	Time Frame
change of perioperative IL-6 level	blood samples assessed by ELISA	up to 6 hours

Other Outcomes

Measure	Description	Time Frame
changes of perioperative hemodynamic parameter	heart rate	up to 3 hours
changes of perioperative hemodynamic parameter	blood pressure	up to 3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of limb fracture
must receiving orthopedic surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
I-Cheng Lu, MD, PHD	Kaohsiung Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
I-Cheng Lu		Kaohsiung City		807	Taiwan
Kaohsiung Municipal Siaogang Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D007431	Intraoperative Complications

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D009407	Nerve Block

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided