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Completed

NCT Number: NCT01007565

Postoperative Pain After Volar Plating for Distal Radius Fractures

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.

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Key information

Age range

16 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of orthopedic surgery, Seoul national university bundang hospital

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

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

periarticular anesthetics injection

Procedure

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 outcomes

  1. postoperative pain level

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 4, 2009
Registry last updated
Nov 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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