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

February 15, 2020 updated by: I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital

Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • I-Cheng Lu
      • Kaohsiung, Taiwan, 812
        • Kaohsiung Municipal Siaogang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nerve block(+)
patient accept nerve block for post-op pain control
Procedure: 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain
Other Names:
  • nerve block with 0.25% bupivacaine
Sham Comparator: Morphine
patient received morphine for post-op pain control
Procedure: 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain
Other Names:
  • nerve block with 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborators

Kaohsiung Municipal Hsiaokang Hospital

Investigators

  • Study Chair: I-Cheng Lu, MD, PHD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-F(I)-20170007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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