Distal Radius FractureNCT02495688
Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting
A study testing Regional anesthesia and General anesthesia in people with Distal Radius Fracture and Postoperative Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Distal Radius Fracture, Postoperative Pain
- What is being tested?
- Regional anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 23 Mar 2015to 16 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-74 years planned for surgery with a volar plate due to displaced distal radius fracture.
Who cannot join
- Dementia,
- alcohol abuse,
- medical condition that interferes with either allocation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Distal Radius Fracture, Postoperative Pain
- Being tested
- Regional anesthesia, General anesthesia
- Keywords
- General Anesthesia, Regional Anesthesia
- Medical subject headings
- Wrist Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaProcedure or surgery
Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.
General anesthesiaProcedure or surgery
Standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia | Experimental | Patients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm. Receives: Procedure: Regional anesthesia |
| General anesthesia | Active comparator | 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. Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.
Measured: 72 hours after day care surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
ROM
Range of motion (ROM) and grip strenght is measured by an unblinded occupational therapist.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start23 Mar 2015
- Primary completion12 Nov 2016
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Enocson, Karolinska Institutet
- Investigators
- Anders Enocson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495688
- Sponsor's protocol ID
- Plx vs GA
- Status last verified
- Jan 2018
- First submitted
- 8 Jul 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22377510
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02495688
- Acronym / sponsor ID
- Plx vs GA
- Conditions
- Distal Radius Fracture, Postoperative Pain
- Keywords
- General Anesthesia, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 12 Nov 2016 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia | Experimental | Procedure: Regional anesthesiaPatients are anesthezised with local aneshtetics administered with ultrasound guidance in the nerval plexus of the arm. |
| General anesthesia | Active comparator | Procedure: General anesthesiaPatients are anesthezised with general anesthesia and orotrachial airway. Local anesthetics (Chirocaine 5 mg/ml, 10 ml) is administered in the surgical wound during surgery. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-74 years planned for surgery with a volar plate due to displaced distal radius fracture.
Key exclusion criteria (3 listed)
- Dementia,
- alcohol abuse,
- medical condition that interferes with either allocation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional anesthesiaStandard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used. | Procedure or surgery | Regional anesthesia |
| General anesthesiaStandard procedure. | Procedure or surgery | General anesthesia |
Primary outcome
Postoperative opioid consumption
Time frame: 72 hours after day care surgery
The total amount of administered and consumed opioids is calculated for the first 72 hours postoperatively.
6 secondary outcomes
Pain
Time frame: 14 days
Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours
PRWE
Time frame: 6 months
EQ5D
Time frame: 6 months
ROM
Time frame: 6 months
X-ray
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 22377510Egol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Enocson, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia and General anesthesia in people with Distal Radius Fracture and Postoperative Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 72 hours after day care surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.