NCT01007565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
Last Updated

November 4, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

November 1, 2009

Last Update Submit

November 3, 2009

Conditions

Distal Radius Fractures

Keywords

periarticular injection

Outcome Measures

Primary Outcomes (1)

  • postoperative pain level

    48 hours

Study Arms (1)

periarticular injection, pain level

EXPERIMENTAL
Procedure: periarticular anesthetics injection

Interventions

periarticular anesthetics injectionPROCEDURE

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.

periarticular injection, pain level

Eligibility Criteria

Age16 Years - 89 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • distal radius fracture with or without a styloid fracture not requiring surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of orthopedic surgery, Seoul national university bundang hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Hyun Sik Gong, Professor

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2009

First Posted

November 4, 2009

Study Start

March 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 4, 2009

Record last verified: 2009-11

Locations

KR(1)