About this trial
The LIMB Study is a prospective, observational pilot study evaluating the feasibility of combined non-invasive hemodynamic and lower-limb tissue oximetry monitoring during prolonged minimally invasive pelvic surgeries performed in lithotomy position. Thirty patients will undergo continuous intraoperative monitoring, with the primary outcome being the frequency and duration of tissue oxygen desaturation events and secondary outcomes examining correlations with postoperative limb pain, sensation, and motor function. The study is non-interventional, poses minimal risk, and aims to generate preliminary data to inform future strategies for early detection and prevention of limb ischemia and well-leg compartment syndrome
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients
Undergoing minimally invasive pelvic surgery (such as hysterectomy, myomectomy, or endometriosis surgery)
Surgery performed in lithotomy position
Expected surgical duration > 2 hours as determined by the primary surgeon
Disqualifiers
Pregnant patients
Procedures expected to last < 2 hours
Open surgical approaches
Minor procedures
Trial population
The study population consists of 30 adult patients undergoing minimally invasive pelvic surgery-including hysterectomy, myomectomy, or endometriosis surgery-performed in the lithotomy position at a single tertiary care center. Eligible patients are those whose procedures are expected to last longer than two hours, placing them at potential risk for lower-limb ischemia related to prolonged positioning. This cohort represents a typical gynecologic surgical population without inclusion of pregnant or other vulnerable individuals
Trial design
Cohort
Prospective
Treatments tested in this trial
Lower-Extremity Perfusion Monitoring
Other interventionThis study involves non-interventional physiologic monitoring only, with no alteration to standard surgical or anesthetic care. After induction of anesthesia, patients will have a non-invasive finger cuff applied for continuous beat-to-beat blood pressure and hemodynamic monitoring, along with bilateral lower-leg tissue oximetry sensors placed over the medial calf to continuously measure tissue oxygen saturation (StO₂) throughout surgery. The monitoring data are recorded for observational analysis only, and postoperative limb pain, sensation, and motor function are assessed once in the recovery unit using standardized 5-point Likert scales
Treatment groups
Trial outcomes
Primary outcomes
StO₂ desaturation episodes
Intraoperative lower-limb tissue oxygenation events, defined as the number and duration of StO₂ desaturation episodes, including a drop \>15% from baseline or an absolute StO₂ \<50% lasting more than 5 minutes, recorded continuously during surgery
Secondary outcomes
Postoperative lower-limb symptoms- Pain
Postoperative lower-limb symptoms assessed in the post-anesthesia care unit using the following rating scale range 1 through 5, the higher the better. 1. No sensation (completely numb) 2. Severely reduced sensation 3. Moderately reduced sensation 4. Slightly reduced sensation 5. Normal sensation
Postoperative lower-limb symptoms-Motor
Rated using the following scale (range 1-5), higher is better, 1. No movement (complete paralysis) 2. Severe motor impairment 3. Moderate motor impairment 4. Slight motor impairment 5. Normal movement
Post-operative Limb symptom- sensation
Using the following scale range 1-5, higher is worst. 1. No pain 2. Mild pain 3. Moderate pain 4. Severe pain 5. Worst possible pain
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