NCT06406647

Brief Summary

The ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig first described the block's use in the ED setting for a variety of indications . This nerve block has classically been described to provide extensive anesthesia for procedures distal to the shoulder, such as elbow dislocations, distal radius fractures, and surgical procedures.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

May 6, 2024

Last Update Submit

June 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • numerical rating pain scale .

    0= no pain , 10 = sever pain

    24 hours

Study Arms (2)

ketamine with bupicavaine

ACTIVE COMPARATOR

(bupivacaine+ ketamine): 40patients received 40 ml of bupivacaine 0.25%(in total 100mg)+1mg per Kg of ketamine)

Other: retrocalvicular block

bupicavacine (control group)

ACTIVE COMPARATOR

(Bupivacaine): 40patients received40 ml of bupivacaine 0.25%(in total 100 mg)+2 ml saline.

Other: retrocalvicular block

Interventions

retrocalvicular block in upper limb orthopedic Surgey

bupicavacine (control group)ketamine with bupicavaine

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing upper limb orthopedic surgery,

You may not qualify if:

  • \- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
  • Altered conscious level.
  • Pregnancy.
  • Body mass index (BMI \> 35).
  • Patients who have difficulty understanding the study protocol.
  • Patients who have any known contraindication to study medications.
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ahmed ismail, lecture

    New Valley University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed ismail, lecture

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture of anesthesia and ICU

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations