Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting

Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting - A Randomized Clinical Trial

The purpose of this study is to compare general and regional anesthesia with regard to postoperative pain in patients who undergo surgery in a day surgery setting due to a displaced distal radius fracture.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Distal Radius Fracture
• Intervention / Treatment: Procedure: Regional anesthesia; Procedure: General anesthesia

Detailed Description

We intend to conduct a single-center randomized clinical trial that will enroll 90 patients planned for surgical treatment with a volar plate due to a displaced distal radius fracture in a day surgery setting. Patients who fulfill all of the inclusion criteria and none of the exclusion criteria (see below) will be approached by an MD and/or a RN in the study group on the day of surgery and provided with verbal and written information. If they give their informed written consent to participate in the study they will be randomized to either general or regional anesthesia. The ratio between the study arms will be 1:1 with 45 patients in each group. All patients will receive standard preoperative oral analgesics. Standard procedures for general and regional anesthesia will be used. The regional anesthesia used is supraclavicular brachial nerve block with short- and medium lasting local anesthetics. Patients who receive general anesthesia will be supervised on a postoperative intensive/intermediate care unit until they are stable and have an acceptable pain level before returning to a regular care unit. All patients leave the hospital on the day of surgery. Following standard procedures at our Orthopaedic department all patients will have a non-circular cast for about two weeks for pain-relieve. It will be removed at the standard two week check-up, at which time the sutures are removed, an X-ray is performed and the patients start non-weight bearing mobilization of the wrist.

The primary outcome is total opioid consumption during the first 72 hours postoperatively. It will be measured as the total amount of oral and iv opioids administered in the hospital before discharge as well as oral opioids that the patients consume after discharge. The patients will document their consumption of analgesics in a study diary and for the first three postoperative days report over telephone what they consumed during the previous 24 hours. For details on secondary outcomes see below. The patients will be interviewed over telephone during the first three postoperative days as well as at two weeks. Questions will include grading of pain on a 10 points VAS-scale, grading of postoperative nausea on a 10 points VAS-scale, if they have experienced postoperative vomiting, and if the would recommend the method of anesthesia to a friend or relative. The fractures will be classified by examining X-rays of the fractures before reduction. Postoperative X-rays will be examined and any remaining dislocation will be documented. The patients will fill out an injury-specific (PRWE) and a generic (EQ5D) form for health-related quality of life at the day of surgery (recall for the week before injury) and at 6 months. At 6 months an occupational therapist will perform a test of range of motion (ROM) and grip strength on all patients.

Furthermore, we intend to do an analysis of the resource utilization in the two groups. Time spent in pre-, peri- and postoperative units will be documented for each patient.

All personal data will be handled in a secure way according to ethical and legal regulations.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Södersjukhuset, Stockholm Soder Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-74 years planned for surgery with a volar plate due to displaced distal radius fracture.

Exclusion Criteria:

• Dementia,
• alcohol abuse,
• medical condition that interferes with either allocation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regional anesthesia; Patients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm.	Procedure: Regional anesthesia; Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.
Active Comparator: General anesthesia; Patients are anesthezised with general anesthesia and orotrachial airway. Local anesthetics (Chirocaine 5 mg/ml, 10 ml) is administered in the surgical wound during surgery.	Procedure: General anesthesia; Standard procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.	72 hours after day care surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Postoperative pain is recorded on a 10 points VAS-scale directly postoperatively, after two hours, at time of discharge, at 24, 48 and 72 hours, as well as at two weeks postoperatively.	14 days
Postoperative Nausea and Vomiting (PONV)	Nausea is recorded on a 10 points VAS-scale directly postoperatively, after two hours, at time of discharge and at 24 postoperatively. Vomiting during the first 24 hours postoperatively is recorded but not quantified.	24 hours
PRWE	The injury-specific form, Patient Rated Wrist Evaluation (PRWE), will be filled out by the participants at the day of surgery (recall for the week before injury) as well as at 6 months postoperatively.	6 months
EQ5D	The generic form for patient-rated health-related quality of life, EQ5D, will be filled out by the participants at the day of surgery (recall for the week before injury) as well as at 6 months postoperatively.	6 months
ROM	Range of motion (ROM) and grip strenght is measured by an unblinded occupational therapist.	6 months
X-ray	X-rays of the fracture taken at the emergency department before reduction, as well as at the standard control at the out-patient clinic at 2 weeks after surgery will be examined.	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource utilisation	The utilisation of resources in terms of time in pre-, peri- and postoperative care units will be recorded.	24 hours

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Enocson, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Egol KA, Soojian MG, Walsh M, Katz J, Rosenberg AD, Paksima N. Regional anesthesia improves outcome after distal radius fracture fixation over general anesthesia. J Orthop Trauma. 2012 Sep;26(9):545-9. doi: 10.1097/BOT.0b013e318238becb.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): November 12, 2016
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Regional Anesthesia; General Anesthesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Plx vs GA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No