Postoperative Pain After Volar Plating for Distal Radius Fractures

Distal Radius Fractures Clinical Trial

Official title:

Postoperative Pain After Volar Plating for Distal Radius Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007565
• Other study ID #: B-0801/053-013
• 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
• 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

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Pain, Postoperative
• Radius Fractures

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