Comparing Efficacity of Analgesia Between Ultrasound-guided Nerve Block and Local Infiltration After Wrist Fracture Surgery

NCT02693288 | Completed

• 1 other identifier: 2013-A00720-45
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Distal radial fracture reparations by volar plating are often managed under regional anaesthesia, but are associated with severe pain when the block ends. Acute post-operative pain may delay rehabilitation, and even be a risk factor for the development of chronic pain. The use of opioids and the inevitable opioid-related side effects further decrease patient satisfaction. A multimodal approach to pain management should include local or regional analgesia technique when possible. In the case of wrist fractures, two methods are available: peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly used for the management of postoperative pain after diverse orthopaedic surgeries. The purpose of this study was to determine the equivalence between ultrasound-guided peripheral nerve block and local infiltration by the surgeon for short-term postoperative analgesia after surgical reparation of isolated closed wrist fractures by volar plating under regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse events were recorded for the first 48 hours following surgery.

Conditions

Postoperative Pain; Wrist Fracture

Keywords

Wrist fracture; postoperative pain; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Mean time interval between the analgesic intervention and the onset of a pain score greater than 3/10 on a Numeric Rating Scale for pain, during the first post operative 48 hours

  48 hours

Study Arms (2)

Ultrasound-guided nerve block

NO INTERVENTION

Local infiltration anesthesia

EXPERIMENTAL

Local infiltration by the surgeon at the end of surgery of perifracture site. A solution of 10 mL of ropivacaine 0,75% is injected in the fracture site, tendon's synovial sheaths, subcutaneous tissue and skin.

Procedure: Local infiltration anesthesia

Interventions

Local infiltration anesthesia PROCEDURE

Local infiltration by the surgeon at the end of surgery of perifracture site. A solution of 10 mL of ropivacaïne 0,75% is injected in the fracture site, tendon's synovial sheaths, subcutaneous tissue and skin.

Local infiltration anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Isolated closed wrist fracture requiring surgical treatment,
• ASA (American Society of Anesthesiologists) score I to III,
• Sufficient level of understanding and expression in french,
• Recipient of a social security regimen (excluding State Medical Aid)

You may not qualify if:

• Psychological or neurological disorder preventing a correct understanding of the study
• Insufficient knowledge of french
• Chronic pain
• Major analgesic ou psychotropic drug
• Drug addiction
• Corticosteroid therapy
• Diabetic neuropathy
• Opioid intolerance (confusion, dizziness, severe constipation, nausea and vomiting, urinary retention)
• Renal or hepatic failure
• Pregnancy or breastfeeding
• Unstable hypertension
• Unstable coronary syndrome
• Contraindication to NSAIDs (peptic ulcer, severe renal failure)
• Known hypersensitivity to ropivacaine or other amid-type local anesthetics
• Open fracture

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de France: collaborator

Study Sites (1)

Saint Antoine Hospital

Paris, Paris, 75012, France

Location

MeSH Terms

Conditions

Pain, Postoperative; Wrist Fractures

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: February 26, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)