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

NCT ID: NCT02495688

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-23
• Study Completion Date: 2017-05-16

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.

Conditions

Distal Radius Fracture; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regional anesthesia

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

Group Type: EXPERIMENTAL

Regional anesthesia

Intervention Type: PROCEDURE

Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.

General anesthesia

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.

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: PROCEDURE

Standard procedure.

Interventions

Regional anesthesia

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

General anesthesia

Standard procedure.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Anders Enocson

M.D, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anders Enocson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Södersjukhuset, Stockholm Soder Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 22377510 (View on PubMed)

Other Identifiers

Plx vs GA

Identifier Type: -

Identifier Source: org_study_id