Postoperative Pain After Volar Plating for Distal Radius Fractures
Primary Purpose
Distal Radius Fractures
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
periarticular anesthetics injection
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fractures focused on measuring periarticular injection
Eligibility Criteria
Inclusion Criteria:
- distal radius fracture with or without a styloid fracture not requiring surgery
Exclusion Criteria:
- multiple trauma
- a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation
- regularly narcotics user
- those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.
Sites / Locations
- Department of orthopedic surgery, Seoul national university bundang hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
periarticular injection, pain level
Arm Description
Outcomes
Primary Outcome Measures
postoperative pain level
Secondary Outcome Measures
Full Information
NCT ID
NCT01007565
First Posted
November 1, 2009
Last Updated
November 3, 2009
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01007565
Brief Title
Postoperative Pain After Volar Plating for Distal Radius Fractures
Official Title
Postoperative Pain After Volar Plating for Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators undertook to evaluate early postoperative pain levels after the volar plating of distal radius fractures performed under regional anesthesia, and to determine whether periarticular multimodal drug injections into the joint, ligament, periosteum, subcutaneous tissue, and skin, and into interosseous and superficial radial nerves (as an additional sensory nerve block) provide additional pain management benefits.
Detailed Description
To evaluate whether periarticular injections (PI) had additional pain management benefits, patients were randomly allocated to two groups, that is, the PI and No-PI groups, using a randomization table. Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure. For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve.
A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve. The anterior interosseous nerve was blocked in the course of the pronator quadratus and posterior interosseous nerve in the 4th dorsal extensor compartment.
The mixture of anesthetics consisted of 2 ampules of ropivacaine HCl (Naropin®, 0.75%, 7.5mg/ml, 20ml/ⓐ), 1 ampule of morphine sulfate (5mg/ⓐ), 1 ampule of epinephrine HCL (1mg/ml, 1ml/ⓐ) and normal saline 20cc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
periarticular injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
periarticular injection, pain level
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
periarticular anesthetics injection
Intervention Description
Members in the PI group received intra-operative periarticular injections and additional sensory nerve blocks just before skin closure . For the periarticular injections and additional sensory block, local analgesic solution was injected into the wrist joint, joint capsule, periosteum, subcutaneous tissue, skin, and around the anterior and posterior interosseous nerves and the superficial radial nerve. A volume of 2ml was injected into the joint capsule and periosteum, and of 3ml into the wrist joint, subcutaneous tissue, skin and into each nerve.
Primary Outcome Measure Information:
Title
postoperative pain level
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
89 Years
Eligibility Criteria
Inclusion Criteria:
distal radius fracture with or without a styloid fracture not requiring surgery
Exclusion Criteria:
multiple trauma
a combined distal radio-ulnar joint instability or a large ulnar styloid fragment requiring fixation
regularly narcotics user
those with a psychiatric illness, a major systemic illness or a known allergy or contraindication to opiates or local anesthetics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Sik Gong, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of orthopedic surgery, Seoul national university bundang hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Postoperative Pain After Volar Plating for Distal Radius Fractures
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