NCT07209995

Brief Summary

The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following the ultrasound-guided retroclavicular infraclavicular approach and the axillary approach in obese patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

September 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

December 16, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

September 30, 2025

Last Update Submit

December 12, 2025

Conditions

Keywords

retroclavicular infraclavicular approach the axillary block obese patients elbow surgeries.

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic request in each group

    24 hours postoperative

Secondary Outcomes (9)

  • Block assessment and definition of successful block

    30 minutes after the block

  • Imaging time

    the time between probe application and insertion of the needle

  • Needle time

    the time between insertion of the needle and complete injection of local anesthetic

  • -Procedure time

    the summation of the imaging and needling times

  • Pain intensity

    basal, one, 2, 4, 8, 12, 16, 20 and 24 hours postoperative

  • +4 more secondary outcomes

Study Arms (2)

Group (R)

ACTIVE COMPARATOR

Patients will recieve retroclavicular infraclavicular brachial plexus block

Other: retroclavicular infraclavicular brachial plexus block for

Group (A)

ACTIVE COMPARATOR

Patients will receive the axillary brachial plexus

Other: axillary block

Interventions

The patient will be placed supine, head facing the contralateral side. A high- frequency 13-6 MHz linear array transducer probe will be placed medial to the coracoid process below and perpendicular to the clavicle to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will be inserted in the supraclavicular fossa, approximately one cm posteriorly to the clavicle, and advanced in plane parallel to the probe. After passing the initial blind zone of about 2 cm caused by the clavicle's acoustic shadow, the needle tip will be continuously seen, until it appears posterior to the axillary artery. A single injection of the local an esthetic will be performed without needle repositioning unless paresthesia is elicited

Group (R)

The axillary nerve block is performed from behind the patient with the patient seated. The axillary nerve will be identified within the quadrilateral space by placing high frequency linear probe parallel to the long axis of the humeral shaft. The nerve was identified next to the circumflex artery

Group (A)

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients acceptance to share in the study.
  • Patients with ASA physical status I-II.
  • Obese patients (BMI 30-40 kg/m²) undergoing around and below elbow surgeries under regional anesthesia.
  • Patients requiring a single injection infraclavicular retroclavicular brachial plexus block or axillary block for around and below elbow surgeries.

You may not qualify if:

  • Patients with a history of allergic reactions or contraindications to local anesthetics.
  • Patients with significant comorbidities (e.g., severe cardiovascular, neurological, or musculoskeletal disorders).
  • Patients with a history of previous shoulder or clavicle surgery that may distort anatomy and affect the efficacy of the block.
  • Pregnant or breastfeeding women.
  • Patients with a history of systemic infections or skin infections in the area of the block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine,zagazig university Egypt

Zagazig, 44519, Egypt

Location

Study Officials

  • Howida A Kamal, MD

    faculty of medicine,zagazig university Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia and surgical intensive care (Principal Investigator)

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 7, 2025

Study Start

October 15, 2025

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

December 16, 2025

Record last verified: 2025-09

Locations