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

NCT ID: NCT03913650

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Pain, Postoperative Change; Circulatory Surgical Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nerve block(+)

patient accept nerve block for post-op pain control

Group Type ACTIVE_COMPARATOR

0.25% bupivacaine

Intervention Type PROCEDURE

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

Morphine

patient received morphine for post-op pain control

Group Type SHAM_COMPARATOR

0.25% bupivacaine

Intervention Type PROCEDURE

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

Interventions

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0.25% bupivacaine

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

Intervention Type PROCEDURE

Other Intervention Names

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nerve block with 0.25% bupivacaine

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Municipal Hsiaokang Hospital

OTHER_GOV

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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I-Cheng Lu

Visiting staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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I-Cheng Lu, MD, PHD

Role: STUDY_CHAIR

Kaohsiung Medical University

Locations

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I-Cheng Lu

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUH-IRB-F(I)-20170007

Identifier Type: -

Identifier Source: org_study_id

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