Prospective Observational Study Comparing GA and WALANT in Distal Radius Fracture Plating Surgery

NCT ID: NCT04549441

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2020-12-31

Brief Summary

The wide-awake local anesthesia no tourniquet (WALANT) has been widely used in the field of hand surgery in recent years. This surgical method has progressed to open reduction and internal fixation of distal radial fracture and radial or ulnar shaft fractures. However, there are still many unclear points for clinicians, including the perioperative subjective feedback from the patient and changes in postoperative pain. In this study, participants having forearm fractures should undergo open reduction and internal fixation were randomized to general anesthesia or WALANT. The investigators will compare the differences in perioperative subjective and objective assessments of these participants during surgery, as well as the prognosis and function after surgery.

Detailed Description

1. Written informed consent must be obtained before any study-specific procedures are undertaken.

2. The process of the experiment A. Include participants into this study, they will be randomized into general anesthesia or WALANT group B. The maximum (toxic) dose of lidocaine was 7 mg/kg. Make distal radius fracture for an example, the solution used in the WALANT technique consisted of 20 ml of 2% lidocaine with epinephrine 1:50,000, which were mixed with normal saline to give a total of 40 ml. A set of baseline parameters, including pulse oximetry, respiratory rate, heart rate, blood pressure, respiratory rate, and oxygen saturation, was obtained during the entire surgery. At the same time, preoperative intravenous antibiotics with 1 g cefazolin were given for each patient as prophylaxis. The amount of blood loss was based upon the amount in a suction container in the operation room. In addition, the investigators will measure the participant's intraoperative subjective satisfaction and pain assessment.

C. After surgery, the participant needs to stay in the in-patient department for one day. The investigators will provide routine prophylactic antibiotics and oral pain pillar. Postoperative pain, sensory, and motor function assessment.

Conditions

WALANT; Radius Fracture Distal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

WALANT

The participants undergo distal radius plating surgery via wide-awake local anesthesia no tourniquet technique. In this group, mean arterial pressure, heart rate, and numeric rating scale for pain were measured by nursing staff in the operation theatre seven times perioperatively, namely before surgery (T0) and at the time of injection of local anesthesia (T1), skin incision (T2), fracture reduction (T3), plating and screwing (T4), skin closure (T5), surgery completion (T6).

Distal radius fracture plating surgery

Intervention Type: PROCEDURE

We performed open reduction and plating surgery for the distal radius fracture.

GA

The participants undergo distal radius plating surgery via general anesthesia induced by an anesthesiologist. The anesthesia team continuously monitored patients' intraoperative physiological status. MAP and HR in group B were marked after induction (T1) and at the other six same time points as in the group WALANT.

Distal radius fracture plating surgery

Intervention Type: PROCEDURE

We performed open reduction and plating surgery for the distal radius fracture.

Interventions

Distal radius fracture plating surgery

We performed open reduction and plating surgery for the distal radius fracture.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with a mature skeleton having a radial fracture

Exclusion Criteria

• Patients having multiple trauma and need to undergo open reduction and internal fixation surgery
• Patients having a concomitant intracranial injury
• Pathological fracture
• Patients refused to be randomized into general anesthesia or WALANT group
• Patients have a history of allergy to anesthetic drugs

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wen-Chih Liu

Attending surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen-Chih Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Municipal Siaogang Hospital

Locations

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Li-Ru Fang

Role: CONTACT

870725@kmuh.org.tw

886-7-8036783 ext. 3475

Facility Contacts

Wen-Chih Liu, MD

Role: primary

1020429@kmuh.org.tw

886-7-803-6783 ext. 3475

Other Identifiers

KMUHIRB-F(I)-20180116

Identifier Type: -

Identifier Source: org_study_id