NCT07352839

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

December 30, 2025

Last Update Submit

January 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety Score

    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 Outcomes (6)

  • Postoperative Pain Score

    From end of surgery to 24 hours postoperatively

  • Opioid Consumption

    From end of surgery to 24 hours postoperatively

  • Number of Participants with Postoperative Nausea and Vomiting (PONV)

    First 24 hours postoperatively

  • PACU Length of Stay

    From PACU admission until discharge readiness (typically 0-4 hours postoperatively

  • Quality of Recovery (QoR-15) Score

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

Brachial Plexus Block Group

ACTIVE COMPARATOR

Patients receiving ultrasound-guided brachial plexus block for upper extremity surgery

Procedure: Brachial Plexus Block

General Anesthesia Group

ACTIVE COMPARATOR

Patients receiving general anesthesia for upper extremity surgery

Procedure: General Anesthesia

Interventions

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.

Brachial Plexus Block Group

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.

General Anesthesia Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Adana, 01150, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Brachial Plexus BlockAnesthesia, General

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Anesthesiology and Reanimation

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 20, 2026

Study Start

May 9, 2025

Primary Completion

November 3, 2025

Study Completion

November 4, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations