Postoperative Pain Clinical Trial
Official title:
Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting - A Randomized Clinical Trial
Verified date | January 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 16, 2017 |
Est. primary completion date | November 12, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 74 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Södersjukhuset, Stockholm Soder Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Resource utilisation | The utilisation of resources in terms of time in pre-, peri- and postoperative care units will be recorded. | 24 hours | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | ROM | Range of motion (ROM) and grip strenght is measured by an unblinded occupational therapist. | 6 months | |
Secondary | 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 |
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