Limb Occlusion Pressure Tourniquets for Surgery Recovery

(LOP Trial)

Overseen By Haley Goble, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Prescription pain medications

Disqualifiers: Fistulas, PVD, Prior trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Currently a standard tourniquet pressure is used for orthopedic surgeries. High tourniquet pressure had been associated with adverse side effects such as ischemia, muscle weakness, and post operative pain. Limb Occlusion Pressure, LOP, is based off the patient's systolic blood pressure plus a safety margin and is typically much lower than standard tourniquet pressure. The aim of this study is to determine if using LOP during orthopedic surgeries decreases post-operative pain and opioid consumption and improves patient's outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on prescription pain medications for chronic conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Limb Occlusion Pressure Tourniquets for Surgery Recovery?

Research shows that using limb occlusion pressure (LOP) to set tourniquet pressures can reduce postoperative pain and complications compared to standard pressures. Studies in various surgeries, like knee and hand surgeries, found that LOP-based settings lead to less pain and fewer complications. ^{1 2 3 4 5}

Is limb occlusion pressure tourniquet use safe for surgery recovery?

Limb occlusion pressure tourniquets are generally considered safe for use in surgeries, as they help reduce the pressure needed compared to standard tourniquets, potentially lowering the risk of complications like postoperative pain and wound issues. Studies suggest that using limb occlusion pressure can lead to fewer complications and better outcomes in surgeries like knee arthroplasty and carpal tunnel surgery. ^{1 2 3 5 6}

How does the Limb Occlusion Pressure treatment differ from other treatments for surgery recovery?

The Limb Occlusion Pressure treatment uses a personalized approach to set tourniquet pressure based on the minimum pressure needed to stop blood flow, which can reduce postoperative pain and complications compared to standard tourniquet pressures. ^{1 2 3 4 5}

Research Team

Patrick McCulloch, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for healthy adults over 18 who are having certain orthopedic surgeries like knee replacements or carpal tunnel release. It's not for those on long-term pain meds, with past trauma/surgery in the limb to be operated on, or with blood vessel issues that prevent tourniquet use.

Inclusion Criteria

I am over 18 and having surgery for carpal tunnel, wrist fracture, cubital tunnel, trigger finger, thumb arthritis, ACL reconstruction, or knee replacement.

Exclusion Criteria

I have been on prescription pain medication for a chronic condition for more than 6 weeks.

Patients who cannot use a tourniquet (e.g. certain patients with fistulas or PVD, certain patients with Peripheral Vascular Disease)

I have had surgery or an injury to the limb being examined.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-operative

Consent obtained and baseline questionnaires completed during a pre-operative office visit

1 day

1 visit (in-person)

Surgery

Participants undergo orthopedic surgery with either standard or limb occlusion pressure tourniquet

1 day

1 visit (in-person)

Post-operative Monitoring

Participants keep a daily pain and opioid consumption diary for two weeks after surgery

2 weeks

Daily self-reporting

Follow-up

Participants complete outcome questionnaires to assess recovery and outcomes

8 weeks

2 visits (in-person or virtual)

Treatment Details

Interventions

• Experimental - Limb Occlusion pressure

Trial Overview The study tests if using Limb Occlusion Pressure (LOP), which is lower than standard tourniquet pressure and based on patient's blood pressure, can reduce post-surgery pain and opioid need, potentially improving recovery outcomes.

Participant Groups

Group I: Experimental - Limb occlusion pressure Experimental Treatment 1 Intervention

This group receives a slightly lower tourniquet pressure than they would during standard of care. This lowered limb occlusion pressure is determined by the tourniquet device.

Group II: Control - Standard pneumatic tourniquet pressure Active Control 1 Intervention

This group receives the standard pneumatic tourniquet pressure during surgery like they would during standard of care.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

The arterial occlusion pressure (AOP) estimation method effectively sets tourniquet inflation pressures in lower limb surgeries, resulting in excellent or good performance in 97.76% of cases across 198 operations involving 224 lower extremities.

Using the AOP method allowed for lower tourniquet pressures (average 173.3 mmHg) than previously recommended, while still achieving a bloodless surgical field, and no complications were reported during or after the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. Tuncalı, B., Boya, H., Kayhan, Z., et al.[2018]

In a study of 244 patients undergoing foot and ankle surgery, an automated tourniquet system that measured limb occlusion pressure (LOP) resulted in significantly lower tourniquet pressures (198.5 mmHg) compared to the control group (259.6 mmHg), indicating a more efficient method for setting pressure.

The use of LOP measurement not only reduced the required tourniquet pressure but also improved the quality of the surgical field, suggesting that this method could enhance surgical outcomes while minimizing potential complications associated with higher pressures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated cuff occlusion pressure effect on quality of operative fields in foot and ankle surgery: a randomized prospective study. Younger, AS., Manzary, M., Wing, KJ., et al.[2014]

In a study of 44 patients undergoing orthopedic hand/wrist surgery, using limb occlusion pressure (LOP) instead of standard tourniquet pressure (STP) significantly reduced post-operative pain medication usage by 50% in the first week.

Patients in the LOP group experienced 80% less pain at the tourniquet site compared to those in the STP group, while both groups reported similar pain levels at the surgical site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limb Occlusion Pressure Versus Standard Pneumatic Tourniquet Pressure in Open Carpal Tunnel Surgery - A Randomized Trial. Morehouse, H., Goble, HM., Lambert, BS., et al.[2022]

In a study of 115 patients undergoing upper limb surgeries, using an arterial occlusion pressure estimation method for setting tourniquet pressure resulted in effective bloodless surgical fields, with 100% effectiveness reported by the surgical team at the end of procedures.

This method allowed for lower tourniquet pressures (mean maximum of 175.5 mmHg) without any observed complications, suggesting it is a safe and practical approach for minimizing pressure-related issues during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of arterial occlusion pressure estimation-based tourniquet pressure settings in upper limb surgery. Tuncali, B., Kokten, G., Boya, H., et al.[2022]

Using the limb-occlusion-pressure (LOP) method significantly lowered the tourniquet cuff pressure during total knee arthroplasty compared to the standard method, which could help reduce the risk of complications.

While there were no significant differences in postoperative pain or complications between the LOP and control groups, patients with a cuff pressure of 225 mm Hg or lower experienced no infections and fewer wound complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. Olivecrona, C., Ponzer, S., Hamberg, P., et al.[2022]

Tourniquet use during extremity surgery is generally safe, but requires careful assessment of patient history and understanding of risks to prevent complications.

Knowledge of the physiological effects of tourniquets, including their impact on skin, vascular health, and postoperative pain, is essential for improving surgical outcomes and ensuring safe perioperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and Optimizing Tourniquet Use During Extremity Surgery. Jensen, J., Hicks, RW., Labovitz, J.[2020]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Clinical utilization of arterial occlusion pressure estimation method in lower limb surgery: effectiveness of tourniquet pressures. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Automated cuff occlusion pressure effect on quality of operative fields in foot and ankle surgery: a randomized prospective study. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Limb Occlusion Pressure Versus Standard Pneumatic Tourniquet Pressure in Open Carpal Tunnel Surgery - A Randomized Trial. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of arterial occlusion pressure estimation-based tourniquet pressure settings in upper limb surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lower tourniquet cuff pressure reduces postoperative wound complications after total knee arthroplasty: a randomized controlled study of 164 patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding and Optimizing Tourniquet Use During Extremity Surgery. [2020]