NCT06004648

Brief Summary

There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

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

July 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 14, 2023

Last Update Submit

August 21, 2023

Conditions

Upper Extremity Problem

Keywords

nerve blockPain, PostoperativeAnesthetics, Local

Outcome Measures

Primary Outcomes (1)

  • peripheral block success

    primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery.

    T1: 12 hours after surgery, T2: 24 hours after surgery

Study Arms (2)

Supraclavicular nerve block

The high- frequency linear USG probe will be placed in the supraclavicular fossa pointing caudally, and the subclavian artery will be localized by moving it medially and laterally. A characteristic honeycomb plexus will be visualized in the lateral and superficial subclavian artery. Vascular structures will be detected using color Doppler, the first rib will be visualized as hyperechoic structure. After the pleura, which makes a sliding movement through the patient\'s breathing is detected, a 22 gauge, 80 mm scale peripheral block needle will be directed from the lateral to the medial by an in-plane technique. After the sheath punctured, nerves will be determined with triceps, biceps, and wrist motor activity by using a nerve stimulator, and then 15 ml of 0.5% bupivacaine will be injected between the 1st rib and the lower trunk.

Procedure: Upper extremity surgery

Selective Trunk Block

Sequential ultrasound imaging technique (SUIT) will be used which is shown successfully in identifying individual elements of the brachial plexus. The neural complex of the upper trunk, middle trunk, and C8 ventral ramus, which are superficial to the T1 TP-1.rip complex will be defined. The first injections contains 8 ml and 7 ml 0.5% bupivacaine will be made as, close to the upper trunk(8ml) and middle trunk(7ml) in the interscalene groove. Then the needle will be completely withdrawn.The ultrasound probe will be placed caudally in the supraclavicular fossa. After providing the optimal view of the lower trunk in the corner pocket, 10 ml of 0.5% bupivacaine will be injected between the first rib and lower trunk.

Procedure: Upper extremity surgery

Interventions

Upper extremity surgeryPROCEDURE

Comparison of 2 different peripheral nerve blocks

Selective Trunk BlockSupraclavicular nerve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Orthopedic surgery patients between 18-65 years of age who needs upper extremity elbow and below-elbow surgery

You may qualify if:

  • \- Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room

You may not qualify if:

  • Patient's refusal
  • ASA IV,
  • Pregnancy,
  • Neuromuscular disease,
  • Peripheral neuropathy
  • Bleeding disorders,
  • Local anesthetic allergy,
  • Infection in the block area
  • Operations without using a tourniquet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zühal Çavuş

Istanbul, Gaziosmanpaşa, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • ZÜHAL ÇAVUŞ

    gaziosmanpasa TREH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of anesthesiology,Clinical Professor

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 22, 2023

Study Start

July 28, 2022

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

TU(1)