Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani

NCT06293209 | Active Not Recruiting DMC

• 1 other identifier: Sunpasitthiprasong Hospital
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear. The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture

Conditions

Ankle Fractures; Swelling; Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

• swelling

  Measuring ankle swelling using the figure-of-eight-20 method, which involves measuring the circumference of the ankle and foot using a tape measure placed along the sides of the foot, passing through specific points,3 time and then averaging the measurements obtained in millimeters.

  5 day before surgery

Secondary Outcomes (1)

• pain score

  48 hours

Study Arms (3)

The control group (non-cryotherapy group)

PLACEBO COMPARATOR

Routine preoperative protocol ankle fracture on short leg slab compression with bandage

Device: Placebo

The cold pack group

ACTIVE COMPARATOR

The cold pack group consists of patients with ankle fractures who receive cold therapy using ice packs sized 20x20 centimeters. The ice packs are placed in the freezer compartment for 30 seconds after they have solidified, then applied to the injured ankle for 10 minutes, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM).

Device: 3M cold pack

The cold spray

ACTIVE COMPARATOR

The cold spray group consists of patients with ankle fractures who receive cold therapy using Perskindol cold spray containing Levomenthol. The spray is applied to the injured ankle 5-6 times, followed by a 10-minute break. This process is repeated every 2 hours for a total of 6 times (from 8:00 AM to 6:00 PM).

Device: Perskindol cold spray

Interventions

3M cold pack DEVICE

3M cold pack

Also known as: cold pack

The cold pack group

Perskindol cold spray DEVICE

Perskindol cold spray

Also known as: cold spray

The cold spray

Placebo DEVICE

Placebo

Also known as: non-cryotherapy treatment

The control group (non-cryotherapy group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thai male and female individuals
• aged 18 years or older.
• diagnosed by the researcher as having unimalleolar fracture, bimalleolar fracture, or trimalleolar fracture requiring surgery.
• capable of reading and writing in the Thai language.

You may not qualify if:

• \- Fractures in both ankles.
• Pathologic fractures of the ankle bones.
• Simultaneous fractures of the ankle and leg bones.
• Previous history of ankle fractures.
• Nerve-related disorders causing inflammation around the ankle.
• Peripheral artery disease causing blockages in the leg arteries.
• Infections in the ankle area.
• Cold allergy.
• Inability to read and write in the Thai language

Sponsors & Collaborators

• Thai Traditional Medical Knowledge Fund: lead

Study Sites (1)

Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand.

Multiple Locations, Ubonrachathani, 34000, Thailand

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Resident of Orthopedics Sunpasitthiprasong hospital, Ubonratchathani, Thailand

Model Details: Population The sample group comprises 30 patients admitted for treatment in the male orthopedic surgery department, female orthopedic surgery department, and accident orthopedic surgery department at Sunpasitthiprasong Hospital, Ubon Ratchathani from August 2023 to January 2024. .

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: August 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: May 28, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)