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Limb Occlusion Pressure Tourniquets for Surgery Recovery (LOP Trial)

N/A
Recruiting
Led By Patrick McCulloch, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once a day, every day for 2 weeks postoperatively
Awards & highlights

LOP Trial Summary

This trial will compare the use of a standard tourniquet pressure to a Limb Occlusion Pressure (LOP) during orthopedic surgeries. The hope is that LOP will decrease post-operative pain and improve patient outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort from the tourniquet, temporary numbness or tingling in the limb due to reduced blood flow during surgery.

LOP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pain will be recorded as an average of three reported vas recordings throughout each day for 14-days following surgery. will compare change in average pain relative baseline pre-op (0) (within group) at each day post-surgery for 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and pain will be recorded as an average of three reported vas recordings throughout each day for 14-days following surgery. will compare change in average pain relative baseline pre-op (0) (within group) at each day post-surgery for 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative surgical site pain
Postoperative tourniquet site pain
Secondary outcome measures
Postoperative opioid usage

LOP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental - Limb occlusion pressureExperimental Treatment1 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 pressureActive Control1 Intervention
This group receives the standard pneumatic tourniquet pressure during surgery like they would during standard of care.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
274 Previous Clinical Trials
80,135 Total Patients Enrolled
Patrick McCulloch, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
3 Previous Clinical Trials
128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery
Shari Liberman 2018. "Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04390425.
~35 spots leftby Dec 2024
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