Regional Nerve Block for Upper Extremity Surgery in Patients With Sarcopenia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorChang Gung Memorial Hospital
About this trial
The goal of this observational study is to learn about the impact of sarcopenia (muscle loss) on the efficacy of regional nerve blocks and postoperative recovery in patients undergoing upper extremity surgery. The main questions it aims to answer are:
1. Does sarcopenia affect the onset time and success rate of peripheral nerve blocks? 2. How does sarcopenia influence postoperative pain control and opioid consumption compared to patients receiving pure general anesthesia?
Participants will undergo a preoperative muscle assessment, which includes a chair stand test and a brief ultrasound of the thigh muscle. Researchers will then observe and record their nerve block onset time (if applicable), postoperative pain scores, and recovery metrics during their hospital stay up to postoperative day 2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>=50 years old
ASA I-III
Receiving upper limb surgery under general anesthesia
Disqualifiers
Severe cognitive impairment or inability to cooperate with pain and motor assessment
Pre-existing neuropathy of the musculocutaneous, median, radial or ulnar nerve
(for nerve block group) Contraindications to regional nerve blockade
Trial population
The study population comprises patients aged 50 years and older with an American Society of Anesthesiologists (ASA) physical status of I to III, who are scheduled to undergo upper extremity surgery under general anesthesia. Eligible participants must be capable of cooperating with postoperative pain and functional assessments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
sarcopenia
Other interventionPatients identified with sarcopenia based on preoperative muscle assessment.
Non-sarcopenia
Other interventionPatients with normal muscle mass based on preoperative muscle assessment.
General Anesthesia
Procedure/Surgeryreceived general anesthesia alone
Nerve Block
Procedure/Surgerygeneral anesthesia combined with nerve block
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: General anesthesia alone3 interventions
Group B: General anesthesia combine infraclavicular brachial plexus block, with sarcopenia3 interventions
Group C: General anesthesia combine infraclavicular brachial plexus block, without sarcopenia3 interventions
Trial outcomes
Primary outcomes
1
time to first rescue analgesia
Time frame
From the completion of surgery up to Postoperative Day 2Secondary outcomes
1
Nerve block onset
Time frame
From the completion of local anesthetic injection up to 30 minutes2
Nerve block duration
Time frame
From the successful onset of sensory block to the patient's first report of pain at the surgical site, assessed up to postoperatively day 23
Intraoperative Mean Arterial Pressure (MAP) and Heart Rate (HR)
Mean Arterial Pressure (MAP) measured in mmHg and Heart Rate (HR) measured in beats per minute, assessed continuously using standard non-invasive or invasive hemodynamic monitors.
Time frame
During surgery (From the induction of anesthesia to the end of surgery, an average of 2 hours)4
Postoperative NRSFrom the end of surgery up to 48 hours postoperatively.
Time frame
From the end of surgery up to postoperative day 2Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: