- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352839
Brachial Plexus Block vs General Anesthesia in Upper Extremity Surgery
Comparison of Brachial Plexus Block Versus General Anesthesia for Upper Extremity Surgery: A Randomized Controlled Trial
This study compares two different anesthesia methods for upper arm and hand surgery: regional anesthesia (brachial plexus block) versus general anesthesia.
Regional anesthesia numbs only the arm being operated on by injecting local anesthetic near the nerves, while the patient remains awake or lightly sedated. General anesthesia puts the patient completely asleep using medications given through a breathing tube.
The main goals of this study are to compare:
- How much pain patients experience after surgery
- Patient satisfaction with their anesthesia
- Side effects such as nausea, vomiting, or breathing problems
- Time until patients are ready to go home
- Overall safety of each method
Participants in this study will be randomly assigned to receive either brachial plexus block or general anesthesia for their scheduled upper extremity surgery. The research team will monitor participants during surgery and follow their recovery for 24 hours after the operation.
This research will help doctors and patients make better-informed decisions about which type of anesthesia may be best for upper extremity procedures.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Adana
-
Adana, Adana, Turkey (Türkiye), 01150
- Adana City Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- clusion Criteria:
- Adults aged 18-65 years
- ASA physical status I-II
- Scheduled for elective upper-extremity orthopedic surgery
- Able to provide informed consent
- Able to understand and complete study questionnaires
Exclusion Criteria:
- Contraindications to regional anesthesia
- Coagulopathy or bleeding disorders
- Local infection at the block site
- Patient refusal of regional anesthesia
- Known allergy to local anesthetic agents
- Chronic opioid use (daily use for >3 months)
- Psychiatric disorders preventing cooperation or consent
- Pregnancy or breastfeeding
- Severe respiratory disease (for general anesthesia group)
- Pre-existing neurological deficit in the operative extremity
- Emergency surgery
- ASA physical status III or higher
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Brachial Plexus Block Group
Patients receiving ultrasound-guided brachial plexus block for upper extremity surgery
|
Ultrasound-guided infraclavicular brachial plexus block using local anesthetic (e.g., ropivacaine or bupivacaine).
Block performed before surgery to provide regional anesthesia for upper extremity surgery.
|
|
Active Comparator: General Anesthesia Group
Patients receiving general anesthesia for upper extremity surgery
|
Standard general anesthesia with intravenous induction and maintenance with volatile anesthetics or total intravenous anesthesia (TIVA).
Endotracheal intubation or laryngeal mask airway used as appropriate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative Anxiety Score
Time Frame: Immediately before operating room entry (preoperatively)
|
Preoperative anxiety measured immediately prior to operating room entry using the State-Trait Anxiety Inventory-State (STAI-S) scale.
STAI-S is a validated 20-item questionnaire assessing current state anxiety.
Scores range from 20 to 80, with higher scores indicating greater anxiety levels.
|
Immediately before operating room entry (preoperatively)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score
Time Frame: From end of surgery to 24 hours postoperatively
|
Pain intensity measured using Visual Analog Scale (VAS) at multiple time points after surgery.
VAS scores range from 0 to 10, where 0 indicates no pain and 10 indicates worst pain imaginable.
Lower scores indicate better outcome.
|
From end of surgery to 24 hours postoperatively
|
|
Opioid Consumption
Time Frame: From end of surgery to 24 hours postoperatively
|
Total opioid consumption measured as morphine equivalent dose (mg) during the postoperative period.
All opioid medications administered were converted to morphine equivalents using standard conversion factors.
Lower consumption indicates better outcome.
|
From end of surgery to 24 hours postoperatively
|
|
Number of Participants with Postoperative Nausea and Vomiting (PONV)
Time Frame: First 24 hours postoperatively
|
Number of participants experiencing postoperative nausea and/or vomiting requiring antiemetic treatment during the postoperative period.
PONV was defined as any episode of nausea or vomiting reported by the patient or requiring rescue antiemetic medication.
|
First 24 hours postoperatively
|
|
PACU Length of Stay
Time Frame: From PACU admission until discharge readiness (typically 0-4 hours postoperatively
|
Duration of stay in the Post-Anesthesia Care Unit (PACU) measured in minutes, from admission to discharge readiness based on standardized discharge criteria (Aldrete score ≥9).
Shorter stay indicates better recovery.
|
From PACU admission until discharge readiness (typically 0-4 hours postoperatively
|
|
Quality of Recovery (QoR-15) Score
Time Frame: 24 hours postoperatively
|
Patient-reported quality of recovery assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire.
QoR-15 is a 15-item instrument measuring five dimensions of recovery: physical comfort, emotional state, psychological support, physical independence, and pain.
Each item is scored 0-10, with total scores ranging from 0 to 150.
Higher scores indicate better quality of recovery.
|
24 hours postoperatively
|
|
Patient Satisfaction Score
Time Frame: 24 hours postoperatively
|
Overall patient satisfaction with anesthesia care measured using a numerical rating scale from 0 to 5, where 0 indicates completely dissatisfied and 5 indicates completely satisfied.
Patients were asked to rate their overall satisfaction with the anesthesia experience.
|
24 hours postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 536
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Regional Anesthesia
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Cairo UniversityRecruiting
-
Societa Italiana Anestesia Analgesia Rianimazione...Not yet recruitingRegional Anesthesia | Regional Anesthesia Block
-
Peking University Third HospitalBeijing Municipal Health CommissionCompletedAnesthesia, Local | Surgery | Regional AnesthesiaChina
-
Ospedale Edoardo BassiniCompletedRegional Anesthesia | Regional Anesthesia Block | Total Hip Replacement Surgery | Total Hip Arthroplasty \(THA\)Italy
-
Assiut UniversityNot yet recruiting
-
Women's College HospitalCompletedAnesthesia, RegionalCanada
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Kocaeli UniversityCompleted
-
Derince Training and Research HospitalCompletedAnesthesia, RegionalTurkey
Clinical Trials on Brachial Plexus Block
-
Bozyaka Training and Research HospitalCompletedComparison of Sympathetic Blockade Duration in Brachial Plexus Blocks Performed by Different MethodsBrachial Plexus Blockade | Anesthesia, Conduction | Sympathetic BlockadeTurkey (Türkiye)
-
Ain Shams UniversityRecruitingBrachial Plexus Blocks | Regional Anesthesia BlockEgypt
-
Shanghai Tong Ren HospitalShanghai 6th People's HospitalNot yet recruitingProximal Humeral Fracture | Anesthesia, Regional | Diaphragmatic ParalysisChina
-
Sargodha Medical CollegeCompletedProcedure TimePakistan
-
Sanliurfa Mehmet Akif Inan Education and Research...RecruitingCerebral Perfusion | Interscalene Block | Superficial Cervical Block | Shoulder SurgeriesTurkey (Türkiye)
-
Shanghai Jiao Tong University Affiliated Sixth...Enrolling by invitation
-
Ankara Etlik City HospitalNot yet recruitingBrachial Plexus Block | Regional Anaesthesia | Perfusion Index | Upper Extremity Surgery
-
Istanbul UniversityCompleted
-
Seoul National University HospitalCompleted
-
Taipei Medical University WanFang HospitalUnknownFinding the Minimum Dose to Induce Sympathectomy in Infraclavicular