Clinical trial NCT02495688: 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
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Postoperative Pain
Keywords: General Anesthesia
Regional Anesthesia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 72 hours after day care surgery
Secondary outcomes:
measure: Pain
timeFrame: 14 days
measure: Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hours
measure: PRWE
timeFrame: 6 months
measure: EQ5D
timeFrame: 6 months
measure: ROM
timeFrame: 6 months
measure: X-ray
timeFrame: 14 days
Other outcomes:
measure: Resource utilisation
timeFrame: 24 hours
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset, Stockholm Soder Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anders Enocson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.