SarcopeniaNCT07757984
Regional Nerve Block for Upper Extremity Surgery in Patients With Sarcopenia
An observational study of Sarcopenia and Nerve Block, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sarcopenia, Nerve Block
- What is being tested?
- sarcopenia, Non-sarcopenia and General Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- Age>=50 years old
- ASA I-III
- Receiving upper limb surgery under general anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
ChangGung Memorial Hospital
Taoyuan
怡廷 Chen, +886 965853825, cheneating23@gmail.com
About this study
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:
- Does sarcopenia affect the onset time and success rate of peripheral nerve blocks?
- 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.
- Conditions
- Sarcopenia, Nerve Block
- Being tested
- sarcopenia, Non-sarcopenia, General Anesthesia, Nerve Block
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopeniaOther
Patients identified with sarcopenia based on preoperative muscle assessment.
Non-sarcopeniaOther
Patients with normal muscle mass based on preoperative muscle assessment.
General AnesthesiaProcedure or surgery
received general anesthesia alone
Nerve BlockProcedure or surgery
general anesthesia combined with nerve block
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia alone | Not described Receives: Other: sarcopenia; Other: Non-sarcopenia; Procedure: General Anesthesia | |
| General anesthesia combine infraclavicular brachial plexus block, with sarcopenia | Not described Receives: Other: sarcopenia; Procedure: General Anesthesia; Procedure: Nerve Block | |
| General anesthesia combine infraclavicular brachial plexus block, without sarcopenia | Not described Receives: Other: Non-sarcopenia; Procedure: General Anesthesia; Procedure: Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first rescue analgesia
Measured: From the completion of surgery up to Postoperative Day 2
Secondary outcomes (8)
Nerve block onset
Measured: From the completion of local anesthetic injection up to 30 minutes
Nerve block duration
Measured: From the successful onset of sensory block to the patient's first report of pain at the surgical site, assessed up to postoperatively day 2
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.
Measured: During surgery (From the induction of anesthesia to the end of surgery, an average of 2 hours)
Postoperative NRSFrom the end of surgery up to 48 hours postoperatively.
Measured: From the end of surgery up to postoperative day 2
Total opioid consumption
Measured: From the end of surgery up to postoperative day 2
Incidence of Local Anesthetic Systemic Toxicity (LAST)
LAST is defined as the occurrence of adverse central nervous system signs (e.g., altered mental status, seizures, tinnitus) or cardiovascular signs (e.g., arrhythmias, profound hypotension, cardiac arrest) following the administration of local anesthetics. It will be assessed clinically by the attending anesthesiologist and recorded as a binary outcome (Yes/No).
Measured: From the initiation of nerve block up to 24 hours postoperatively
Incidence of postoperative delirium
The incidence of postoperative delirium will be assessed using the Confusion Assessment Method (CAM). The CAM diagnostic algorithm evaluates four features: (1) acute onset and fluctuating course, (2) inattention, (3) disorganized thinking, and (4) altered level of consciousness. Delirium is considered present if features 1 and 2 are observed, along with either feature 3 or 4. The outcome will be recorded as a binary variable (Yes/No).
Measured: From the end of surgery up to postoperative day 2
ICU stay
Measured: From ICU admission up to postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757984
- Sponsor's protocol ID
- 202601219B0
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Nerve Block for Upper Extremity Surgery in Patients With Sarcopenia
- ClinicalTrials.gov ID
- NCT07757984
- Acronym / sponsor ID
- 202601219B0
- Conditions
- Sarcopenia, Nerve Block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does sarcopenia affect the onset time and success rate of peripheral nerve blocks?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia alone | – | Other: sarcopenia, Other: Non-sarcopenia, Procedure: General Anesthesia |
| General anesthesia combine infraclavicular brachial plexus block, with sarcopenia | – | Other: sarcopenia, Procedure: General Anesthesia, Procedure: Nerve Block |
| General anesthesia combine infraclavicular brachial plexus block, without sarcopenia | – | Other: Non-sarcopenia, Procedure: General Anesthesia, Procedure: Nerve Block |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Age>=50 years old
- ASA I-III
- Receiving upper limb surgery under general anesthesia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sarcopeniaPatients identified with sarcopenia based on preoperative muscle assessment. | Other | General anesthesia alone, General anesthesia combine infraclavicular brachial plexus block, with sarcopenia |
| Non-sarcopeniaPatients with normal muscle mass based on preoperative muscle assessment. | Other | General anesthesia alone, General anesthesia combine infraclavicular brachial plexus block, without sarcopenia |
| General Anesthesiareceived general anesthesia alone | Procedure or surgery | General anesthesia alone, General anesthesia combine infraclavicular brachial plexus block, with sarcopenia, General anesthesia combine infraclavicular brachial plexus block, without sarcopenia |
| Nerve Blockgeneral anesthesia combined with nerve block | Procedure or surgery | General anesthesia combine infraclavicular brachial plexus block, with sarcopenia, General anesthesia combine infraclavicular brachial plexus block, without sarcopenia |
Primary outcome
time to first rescue analgesia
Time frame: From the completion of surgery up to Postoperative Day 2
8 secondary outcomes
Nerve block onset
Time frame: From the completion of local anesthetic injection up to 30 minutes
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 2
Intraoperative Mean Arterial Pressure (MAP) and Heart Rate (HR)
Time frame: During surgery (From the induction of anesthesia to the end of surgery, an average of 2 hours)
Postoperative NRSFrom the end of surgery up to 48 hours postoperatively.
Time frame: From the end of surgery up to postoperative day 2
Total opioid consumption
Time frame: From the end of surgery up to postoperative day 2
Incidence of Local Anesthetic Systemic Toxicity (LAST)
Time frame: From the initiation of nerve block up to 24 hours postoperatively
Incidence of postoperative delirium
Time frame: From the end of surgery up to postoperative day 2
ICU stay
Time frame: From ICU admission up to postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tsai principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Nerve Block, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Ting Chen (+886 965853825, cheneating23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first rescue analgesia (time frame: From the completion of surgery up to Postoperative Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.