- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007565
Postoperative Pain After Volar Plating for Distal Radius Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
- Department of orthopedic surgery, Seoul national university bundang hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: periarticular injection, pain level
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative pain level
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Hyun Sik Gong, Professor, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-0801/053-013
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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