Postoperative Pain After Volar Plating for Distal Radius Fractures

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01007565
First received: November 1, 2009
Last updated: November 3, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Distal Radius Fractures
Procedure: periarticular anesthetics injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Postoperative Pain After Volar Plating for Distal Radius Fractures

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • postoperative pain level [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: periarticular injection, pain level 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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 89 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007565

Locations
Korea, Republic of
Department of orthopedic surgery, Seoul national university bundang hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Study Director: Hyun Sik Gong, Professor Seoul National University Bundang Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01007565     History of Changes
Other Study ID Numbers: B-0801/053-013
Study First Received: November 1, 2009
Last Updated: November 3, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
periarticular injection

Additional relevant MeSH terms:
Fractures, Bone
Pain, Postoperative
Radius Fractures
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Forearm Injuries
Arm Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014