NCT04293354

Brief Summary

Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic. Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

February 29, 2020

Last Update Submit

February 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    Tramadol

    up to 24 hour

Secondary Outcomes (1)

  • Numerical Rating Scale (NRS)

    at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

Study Arms (2)

Serratus Plane Block

ACTIVE COMPARATOR

The Serratus plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Procedure: Serratus Plane Block

Control

SHAM COMPARATOR

No block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.

Procedure: Control

Interventions

Serratus Plane Block was performed

Serratus Plane Block
ControlPROCEDURE

No block was performed

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III

You may not qualify if:

  • Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University Hospital

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (2)

  • Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.

    PMID: 28447227BACKGROUND
  • Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

August 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

March 3, 2020

Record last verified: 2020-02

Locations