Postoperative Pain After Volar Plating for Distal Radius Fractures

Phase 2

Completed

• Conditions: Distal Radius Fractures
• Interventions: Procedure: periarticular anesthetics injection

• Registration Number: NCT01007565
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study Start: 2008-03
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-11
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-03
• Last Update Submitted: 2009-11-03
• Study First Posted: 2009-11-04
• Last Update Posted: 2009-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
periarticular injection, pain level	periarticular anesthetics injection	-

Primary Outcome Measures

Name	Time	Method
postoperative pain level	48 hours

Trial Locations

Locations (1)

Department of orthopedic surgery, Seoul national university bundang hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of