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

Primary Purpose

Distal Radius Fracture, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Regional anesthesia
General anesthesia
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring General Anesthesia, Regional Anesthesia

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Södersjukhuset, Stockholm Soder Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regional anesthesia

General anesthesia

Arm Description

Patients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm.

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.

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.

Secondary Outcome Measures

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.
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.
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.
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.
ROM
Range of motion (ROM) and grip strenght is measured by an unblinded occupational therapist.
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.

Full Information

First Posted
July 8, 2015
Last Updated
January 21, 2018
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02495688
Brief Title
Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting
Official Title
Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 23, 2015 (Actual)
Primary Completion Date
November 12, 2016 (Actual)
Study Completion Date
May 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Postoperative Pain
Keywords
General Anesthesia, Regional Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional anesthesia
Arm Type
Experimental
Arm Description
Patients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia
Intervention Description
Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
Standard procedure.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.
Time Frame
72 hours after day care surgery
Secondary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
14 days
Title
Postoperative Nausea and Vomiting (PONV)
Description
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.
Time Frame
24 hours
Title
PRWE
Description
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.
Time Frame
6 months
Title
EQ5D
Description
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.
Time Frame
6 months
Title
ROM
Description
Range of motion (ROM) and grip strenght is measured by an unblinded occupational therapist.
Time Frame
6 months
Title
X-ray
Description
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.
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Resource utilisation
Description
The utilisation of resources in terms of time in pre-, peri- and postoperative care units will be recorded.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Enocson, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södersjukhuset, Stockholm Soder Hospital
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22377510
Citation
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.
Results Reference
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Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting

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