Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery

NCT ID: NCT04390425

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

The study will start for each subject in the clinic setting during a standard pre-operative office visit. Consent for the study will be obtained after explaining all aspects of the study. The subjects will be randomly separated into two groups. Half of the subjects will have their procedure performed under standard tourniquet pressure, and the other half of the subjects will have their procedure performed with a distal photoplenthysmography probe that will calculate Limb Occlusion Pressure and inflate the tourniquet to the calculated Limb Occlusion Pressure. The subject will undergo their scheduled procedure in the operating room. The subject will also keep a daily pain and opioid consumption diary at home for two weeks after the surgery. The subject will complete patient outcome questionnaires before the surgery, two weeks after the operation, and 8 weeks after the operation to assess patient outcomes. The subject can complete the questionnaires at home, but if they do not, they will have the option to fill the out during their clinic visits. The patient's pre and post OP questionaries' will be the indicators for patient outcomes. All of the standardized questionnaires give calculated scores based off the patients' responses. As the subject improves their score will increase.The research team can compare change in score between the two groups and change with in groups to access patient outcomes.

To maintain the double blind nature of the study, the tourniquet will be placed, inflated, and draped over before the surgeon enters the operating room. Someone else on the research team, one of the coordinators or one of the residents will record the patients' systolic blood pressure and cuff pressure of the tourniquet before the attending enters the OR. This way the surgeon is still blind to the cuff pressure technique used, LOP or STP, when they rate the quality of the bloodless field after the surgery using a VAS scale.

All of these documents are attached on the summary page under additional documents on the Psycho-Physiological Testing page under number 1. List all the measures/instruments that will be used for this study. The VAS pain and opioid consumption diary is titled LOP pain diary cover page and LOP pain diary. The questionnaires that will be used are DASH, IKDC Subject Knee Evaluation Form, KOOS Junior, KOOS Lysholm, Marx, Michigan Hand Outcomes, Patient Rated Wrist Evaluation, Promis Bank v 1.2 Physical Function, PROMIS SF v 1.1 Global Health, and Tegner Activity Level Scale.

Conditions

Limb Occlusion Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control - Standard pneumatic tourniquet pressure

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental - Limb occlusion pressure

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 Type: EXPERIMENTAL

Experimental - Limb Occlusion pressure

Intervention Type: DEVICE

This intervention involves lower tourniquet pressure than the standard of care. There is no change to tourniquet time or how the surgery is performed.

Interventions

Experimental - Limb Occlusion pressure

This intervention involves lower tourniquet pressure than the standard of care. There is no change to tourniquet time or how the surgery is performed.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The research team will test the central hypothesis that LOP tourniquets will decrease pain and opioid use and improve patients outcomes on healthy adults (above the age of 18) undergoing either open carpal tunnel release, open reduction internal fixation distal radius fracture, cubital tunnel release, trigger finger release, thumb CMC arthroplasty, anterior cruciate ligament reconstruction, or total knee replacements

Exclusion Criteria

1. Prescription pain medications for chronic conditions (> 6 weeks)

2. Patients who cannot use a tourniquet:( ex. Certain patients with fistulas or PVD, certain patient with Peripheral Vascular Disease)

3. Prior trauma or surgery to the observed limb.

4. Hypotension or hypertension that prevents accurate distal photoplenthysmography probe reading.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Shari Liberman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick McCulloch, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Haley Goble, MHA

Role: CONTACT

hmgoble@houstonmethodist.org

7134413930

Facility Contacts

Haley Goble, MHA

Role: primary

hmgoble@houstonmethodist.org

713-441-3930

References

Aflatooni J, Goble H, Lambert B, Liberman S, McCulloch PC. Limb Occlusion Pressure Versus Standard Pneumatic Tourniquet Pressure in Anterior Cruciate Ligament Surgery: A Randomized Controlled Trial. J Am Acad Orthop Surg Glob Res Rev. 2025 Apr 30;9(5):e24.00282. doi: 10.5435/JAAOSGlobal-D-24-00282. eCollection 2025 May 1.

Reference Type: DERIVED

PMID: 40326965 (View on PubMed)

Other Identifiers

Pro00018544

Identifier Type: -

Identifier Source: org_study_id