NCT06269562

Brief Summary

Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 6, 2024

Last Update Submit

February 13, 2024

Conditions

Keywords

serratus posterior superior intercostal plane blockclavipectoral plane blockclavicle fracturepain management

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale

    0=no pain , 10= the worst pain

    24 hours after the procedure

Secondary Outcomes (1)

  • tramadol consumption

    24 hours after the procedure

Study Arms (1)

Block

EXPERIMENTAL

consists of 5 patients in whom both techniques were applied

Procedure: Serratus posterior superior intercostal plane block and clavipectoral plane block

Interventions

The analgesic effectiveness achieved by the concurrent application of these two techniques was investigated.

Block

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Five American Society of Anesthesiologists (ASA) Ⅰ-II- III patients scheduled for clavicle surgery will be included in the study

You may not qualify if:

  • patients with bleeding disorders
  • patients with signs of infection in the block application area
  • patients with unstable haemodynamics
  • patients with thyroid cardiovascular, renal, hepatic and neuropsychiatric diseases
  • patients with vascular disease,
  • patients with respiratory distress
  • patients whose consent for the study could not be obtained or who did not accept to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor, Department of Anesthesiology and Reanimation

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 21, 2024

Study Start

June 20, 2023

Primary Completion

December 20, 2023

Study Completion

February 4, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations