Back to resultsThe Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
Primary Purpose
Pain, Postoperative, Change; Circulatory, Surgical Injury
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
0.25% bupivacaine
Sponsored by
About this trial
This is an interventional health services research trial for Pain, Postoperative focused on measuring peripheral nerve block, IL-6, post-operative pain, limb surgery
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
Sites / Locations
- I-Cheng Lu
- Kaohsiung Municipal Siaogang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Nerve block(+)
Morphine
Arm Description
patient accept nerve block for post-op pain control
patient received morphine for post-op pain control
Outcomes
Primary Outcome Measures
peak pain intensity in the postoperative care unit
pain score evaluated by pain score
Secondary Outcome Measures
change of perioperative IL-6 level
blood samples assessed by ELISA
Full Information
NCT ID
NCT03913650
First Posted
September 17, 2017
Last Updated
February 15, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Municipal Hsiaokang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03913650
Brief Title
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
Official Title
Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators
Kaohsiung Municipal Hsiaokang Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Change; Circulatory, Surgical Injury
Keywords
peripheral nerve block, IL-6, post-operative pain, limb surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nerve block(+)
Arm Type
Active Comparator
Arm Description
patient accept nerve block for post-op pain control
Arm Title
Morphine
Arm Type
Sham Comparator
Arm Description
patient received morphine for post-op pain control
Intervention Type
Procedure
Intervention Name(s)
0.25% bupivacaine
Other Intervention Name(s)
nerve block with 0.25% bupivacaine
Intervention Description
nerve block procedure will be decided by patients' will for post-op pain
Primary Outcome Measure Information:
Title
peak pain intensity in the postoperative care unit
Description
pain score evaluated by pain score
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
change of perioperative IL-6 level
Description
blood samples assessed by ELISA
Time Frame
up to 6 hours
Other Pre-specified Outcome Measures:
Title
changes of perioperative hemodynamic parameter
Description
heart rate
Time Frame
up to 3 hours
Title
changes of perioperative hemodynamic parameter
Description
blood pressure
Time Frame
up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Cheng Lu, MD, PHD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
I-Cheng Lu
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Municipal Siaogang Hospital
City
Kaohsiung
ZIP/Postal Code
812
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery
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