NCT06958549

Brief Summary

  • Epidemiology \& Impact Thoracic trauma is a common and serious injury worldwide-especially in developing countries-and carries high rates of morbidity and mortality. Complications arise primarily from hypoventilation, which leads to atelectasis, pneumonia, and respiratory failure.
  • Key to Reducing Complications: Pain Control Effective analgesia is the cornerstone of preventing respiratory complications. Inadequate pain relief causes patients to splint and hypoventilate, setting the stage for pulmonary collapse and infection.
  • Conservative Management
  • Analgesics: Systemic pharmacological pain relief remains the mainstay.
  • Supportive Measures: Rest, application of ice, and encouragement of deep breathing exercises.
  • Incentive Spirometry: Promoted in all patients to maintain lung expansion and ward off atelectasis.
  • Regional Anesthesia Techniques To further improve comfort and respiratory mechanics, ultrasound-guided nerve blocks are employed according to fracture location:
  • Serratus Anterior Plane Block for anterolateral rib fractures
  • Thoracic Paravertebral Block for posterior rib fractures
  • Surgical Intervention Reserved for complex cases-such as flail chest or fractures with risk of organ injury-where stabilization or repair may be necessary.
  • Identified Gap Despite these options, thoracic surgeons currently lack a standardized, procedure-specific pain management protocol beyond systemic analgesics, highlighting a need for consensus guidelines that integrate pharmacological and regional techniques.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
11mo left

Started Dec 2025

Status
not yet 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

Study Progress32%
Dec 2025Apr 2027

First Submitted

Initial submission to the registry

April 16, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

April 16, 2025

Last Update Submit

April 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in patients pain score (neumerical score)

    day 0, day 1 and day 3

Secondary Outcomes (3)

  • improving intercostal tube duration in days

    day 2, day 4 and day 6

  • improving total hospital stay in days

    day 2, day 4 and day 6

  • improving patient satisfaction (questionnaire)

    day 0, day 2, day 4 and day 6

Study Arms (2)

nerve block

ACTIVE COMPARATOR
Procedure: Nerve block with Lidocain

pharmacological analgesics

ACTIVE COMPARATOR
Drug: pharmacological analgesics

Interventions

Injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under Ultrasonographical guidance

nerve block

Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)

pharmacological analgesics

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All trauma adult patient (18-70 years) with multiple fracture ribs

You may not qualify if:

  • Patient with multiple fracture rib with anterior flail segment
  • Significant head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.

    PMID: 35106815BACKGROUND
  • Yayik AM, Aydin ME, Tekin E, Ulas AB, Ahiskalioglu A. An alternative plane block for multiple rib fractures: Rhomboid Intercostal and Sub-Serratus block (RISS). Am J Emerg Med. 2019 Dec;37(12):2263.e5-2263.e7. doi: 10.1016/j.ajem.2019.158429. Epub 2019 Sep 6.

    PMID: 31526541BACKGROUND
  • Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.

    PMID: 25210700BACKGROUND
  • Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.

    PMID: 11548565BACKGROUND

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2025

First Posted

May 6, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 6, 2025

Record last verified: 2025-04