Regional or General Anesthesia for Distal Radius Fracture Surgery in a Day Surgery Setting
Condition: Distal Radius Fracture; Postoperative Pain
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

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.
    

Intervention name(s): Regional anesthesia; General anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.; Standard procedure.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: General Anesthesia; Regional Anesthesia