Effectiveness of Low Volume Versus High Volume of Local Anesthetic in Ultrasound Guided Combined Supraclavicular and Interscalene Block for Upper Limb Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
The aim of this study is to evaluate the effectiveness of low versus high volumes of local anesthetic in ultrasound-guided combined supraclavicular block (SCB) and interscalene block (ISB) for upper limb surgery. This randomized, controlled trial will assess the analgesic effectiveness of low-volume local anesthetic in these blocks. We hypothesize that a low volume will provide similar analgesic effects to a high volume, with fewer complications. The study will involve 40 adult ASA I and ASA II patients undergoing upper limb surgery, divided into two groups: Group A (low volume) and Group B (high volume). The primary outcome will compare intraoperative and postoperative analgesic effects of different volumes. The secondary outcome will evaluate complications related to local anesthetics (toxicity) and injection techniques (e.g., phrenic nerve palsy, pneumothorax, hematoma).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 19, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedJuly 23, 2025
July 1, 2025
7 months
June 11, 2025
July 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analgesia
The primary outcome of this study will be to compare the analgesic and anesthetic effect of different volumes of local anesthetic in Ultrasound guided combined SCB with ISB for upper limb surgery. measured by Visual analogue scale score score (VAS) (0-10; with 0 means no pain and 10 means most severe pain).
From time of injection to end of first 24 hours
Secondary Outcomes (4)
complications of local anesthetic
From time of injection to end of surgery
complications of technique of injection
From time of injection to end of 24 hours postoperative
Heart Rate (HR) beat/minute
before induction of anesthesia and every 15 minutes till end of surgery
Mean Arterial Blood Pressure ( MAP)( mmHg)
Before anesthesia, after induction of analgesia and every 15 minutes during surgery
Study Arms (2)
Group A (n=20); Low volume Local anesthetic (15-20 ml)
EXPERIMENTAL20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%) and Interscalene Block (ISB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%).
Group B: ( n=20); High volume local anesthetic ( 30-40ml)
ACTIVE COMPARATOR20 patients, will receive ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10ml lidocaine 2%) and Interscalene Block (ISB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%).
Interventions
Group A; will receive ultrasound guided combined Supraclavicular Block (SCB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%) and Interscalene Block (ISB) with 7-10 ml (3.5-5 ml bupivacaine 0.5% plus 3.5-5 ml lidocaine 2%).
Group B; High volume local anesthetics in ultrasound guided combined Supraclavicular Block (SCB) with 15-20 ml (7.5-10ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%) and Interscalene Block (ISB) with 15-20 ml (7.5-10 ml bupivacaine 0.5% plus 7.5-10 ml lidocaine 2%).
Eligibility Criteria
You may qualify if:
- Patients aged 18 to 65 of both sexes
- ASA classification I or II
- Scheduled for upper limp surgery
- Will be randomized 1:1 into two groups; group A; low volume local anesthetics (15-20ml) and group B; high volume local anesthetics (30-40 ml).
You may not qualify if:
- Patients who refuse participation.
- Have allergies to local anesthetics.
- Phrenic nerve dysfunction.
- Chronic opioid use.
- ASA III or higher classification.
- Coagulopathy (bleeding disorders with INR \> 1.5 and/or platelets \< 50 000)
- Severe chronic obstructive pulmonary disease.
- Local infection at the injection site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Souad Kafafi University Hospital (SKUH), faculty of medicine, Misr University for Science and Technology (MUST)
Giza, Giza Governorate, 15525, Egypt
Related Publications (3)
Falyar CR, Grossman EC. Ultrasound-guided interscalene-supraclavicular block for an intramedullary nailing of a pathologic humeral fracture: practical application of ultrasound-guided regional anesthesia. AANA J. 2014 Jun;82(3):219-22.
PMID: 25109160BACKGROUNDHadzic A. Hadzic's Textbook of Regional Anesthesia and Acute Pain Management. 2nd ed. New York: McGraw-Hill; 2017. p. 44.
BACKGROUNDFredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PMID: 20565394BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hossam S. El Din El Ashmawi, Prof. of anesthesia and pain
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- randomized controlled double blinded study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia & pain management
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 19, 2025
Study Start
June 30, 2025
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- from 01/02/2026 to 31/03/2026
- Access Criteria
- Researchers: Who: Academic researchers, industry scientists, and regulatory agencies. What: Full IPD, including demographic data, treatment assignments, and outcome measures. How: Through data sharing platforms or repositories after submitting a research proposal and obtaining necessary approvals. Regulatory Authorities: Who: Agencies like the FDA or EMA. What: Full IPD and supporting documentation for oversight and review. How: Direct access during the review process of clinical trial applications. Data Sharing Initiatives: Who: Collaborating institutions and consortia. What: Aggregated or anonymized IPD for meta-analyses or systematic reviews. How: Via established partnerships and shared databases. Public and Patient Advocacy Groups: Who: Organizations seeking to promote transparency. What: Summary data and aggregated results, but not individual-level data. How: Through publicly available reports or dashboards.
Demographic Information: Age, sex, race, and other relevant demographic details. Baseline Characteristics: Health status, medical history, and any pre-existing conditions prior to the trial. Treatment Assignment: Information on the intervention or treatment each participant received. Outcome Measures: Data on primary and secondary outcomes as defined in the trial protocol. Adverse Events: Reports of any side effects or adverse events experienced by participants during the trial. Follow-up Data: Information collected during follow-up periods, including long-term outcomes.