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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913650
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Kaohsiung Municipal Hsiaokang Hospital
Information provided by (Responsible Party):
I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Change; Circulatory Surgical Injury Procedure: 0.25% bupivacaine Not Applicable

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 without nerve blocks. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. The primary outcome will be measured by the intra- and post-operative IL-6 level. The secondary outcomes will be assessed by postoperative pain intensity, perioperative analgesics and hemodynamic stability throughout the surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Influence of Preoperative Peripheral Nerve Block on Pain Control and IL-6 Level in Limb Orthopedic Surgery
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nerve block(+)
patient accept nerve block after anesthesia for post-op pain control
Procedure: 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain
Other Name: nerve block with 0.25% bupivacaine

Sham Comparator: Nerve block (-)
patient don't accept nerve block after anesthesia for post-op pain control
Procedure: 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain
Other Name: nerve block with 0.25% bupivacaine




Primary Outcome Measures :
  1. peak NRS in the PACU [ Time Frame: 2 hours ]
    pain score evaluated by NRS


Secondary Outcome Measures :
  1. change of perioperative IL-6 level [ Time Frame: up to 6 hours ]
    blood samples assessed by ELISA


Other Outcome Measures:
  1. changes of perioperative hemodynamic parameter [ Time Frame: up to 3 hours ]
    heart rate

  2. changes of perioperative hemodynamic parameter [ Time Frame: up to 3 hours ]
    blood pressure



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913650


Locations
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Taiwan
I-Cheng Lu
Kaohsiung, Taiwan, 807
Kaohsiung Municipal Siaogang Hospital
Kaohsiung, Taiwan, 812
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Municipal Hsiaokang Hospital
Investigators
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Study Chair: I-Cheng Lu, MD, PHD Kaohsiung Medical University

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Responsible Party: I-Cheng Lu, Visiting staff, Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03913650    
Other Study ID Numbers: KMUH-IRB-F(I)-20170007
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by I-Cheng Lu, Kaohsiung Medical University Chung-Ho Memorial Hospital:
peripheral nerve block
IL-6
post-operative pain
limb surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Intraoperative Complications
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents