Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01007565
Other study ID # B-0801/053-013
Secondary ID
Status Completed
Phase Phase 2
First received November 1, 2009
Last updated November 3, 2009
Start date March 2008
Est. completion date April 2009

Study information

Verified date November 2009
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers
Gender Both
Age group 16 Years to 89 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Procedure:
periarticular anesthetics injection
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.

Locations

Country Name City State
Korea, Republic of Department of orthopedic surgery, Seoul national university bundang hospital Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain level 48 hours No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06453447 - Prednisone for CRPS in Distal Radius Fracture N/A
Recruiting NCT06136286 - ORIF Distal Radius Blood Flow Restriction Therapy N/A
Not yet recruiting NCT06078371 - Opioid-Free Pain Treatment in Trauma Patients N/A
Not yet recruiting NCT05902442 - A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures. N/A
Completed NCT02990052 - Conservative Treatment vs. Volar Plating of Distal Radius Fractures N/A
Withdrawn NCT00788190 - Treatment of Distal Radius Fractures in Elderly Patients N/A
Completed NCT06343467 - Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? N/A
Recruiting NCT06046404 - Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department N/A
Not yet recruiting NCT06251206 - Impact of Early ADL Education on Outcomes Post DRF ORIF Phase 1
Completed NCT00654615 - Fixation of Unstable Distal Radius Fractures N/A
Completed NCT01937624 - Pediatric Distal Radius US Study
Terminated NCT01859468 - A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures Phase 1/Phase 2
Completed NCT01103297 - 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Phase 4
Completed NCT05942950 - Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
Completed NCT06215872 - Effectiveness of Structured Myofacial Chain Exercises After Distal Radius Fracture N/A
Suspended NCT01693094 - A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome N/A
Not yet recruiting NCT06235957 - Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures N/A
Recruiting NCT06019585 - Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures N/A
Terminated NCT02802774 - Immobilization of Postoperative Distal Radius Fractures N/A
Enrolling by invitation NCT05086224 - Hematoma Block Versus Bier Block for Closed Fracture Reduction Early Phase 1