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Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery

NCT04390425 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Limb Occlusion Pressure

Interventions

DEVICE

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.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Patrick McCulloch, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2025-07-28
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390425 on ClinicalTrials.gov