Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release

The University of Chicago

Status: Enrolling

Conditions: Perioperative/Postoperative Complications; Carpal Tunnel Syndrome

Treatments: Other: Standard of care ice therapy; Other: Polarcare Machine

Study type: Interventional

Funder types: Other

Identifiers

NCT05783245

IRB21-1298

Details and patient eligibility

About

This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

Full description

Post-operative pain control is paramount to all operative procedures and involves several modalities. Both pharmaceutical and non-pharmaceutical measures are frequently used. Carpal tunnel release (CTR) surgery is one of the most common surgeries performed in the U.S. with over 400,000 procedures per year.2 Frequently, ice is used as a treatment modality following surgical CTR.3 Several products have been developed in the past decades to improve ice therapy in the rehabilitation period. One such product is the Polar Care which provides up to 6-8 hours of continuous icing.

While there is good data supporting the use of cooling therapy (ice) for post-operative pain, there is lack of data surrounding the use of continuous cooling therapy machines such as the PolarCare following carpal tunnel release (CTR). The two papers that evaluated the efficacy of continuous cooling therapy following CTR had conflicting results on any added benefit of continuous cooling therapy over traditional icing.

There is no standard of care for post-operative icing at UCMC following CTR. Clinicians currently decide whether to give patients a PolarCare machine on the day of surgery without any algorithm. All other patients are encouraged to use traditional icing methods. This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

The investigators hypothesize that participants receiving continuous cooling therapy will have a statistically significantly lower pain score compared to those receiving traditional ice therapy.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 or older
2. Indicated for open carpal tunnel release
3. Able and willing to complete online questionnaires

Exclusion criteria

1. Prior carpal tunnel surgery for ipsilateral extremity
2. Additional procedures to be performed on ipsilateral or contralateral extremity
3. Current opioid or narcotic pain medication usage

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

Experimental Ice Therapy

Experimental group

Description:

Postoperative care with experimental ice therapy

Treatment:

Other: Polarcare Machine

Standard of Care Ice Therapy

Active Comparator group

Description:

Postoperative care with standard of care ice therapy

Treatment:

Other: Standard of care ice therapy