Adana City Training and Research Hospital
Adana, 01150, Turkey (Türkiye)
NCT Number: NCT07352839
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Adana, 01150, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
Adana City Training and Research Hospital
Other
Comparison of Brachial Plexus Block Versus General Anesthesia for Upper Extremity Surgery: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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