Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma: a Feasibility Randomised Controlled Trial With Embedded Qualitative Assessment

NCT07494851 | Completed

• 1 other identifier: 21AN002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

To assess the feasibility and inform the design and conduct of a pragmatically conducted, interventional, multi-centre RCT in adult patients admitted to UK major trauma centres with rib fractures examining ESP block as an analgesic adjunct to existing multimodal analgesia in the early management of rib fracture pain.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (3)

• Recruitment rate vs target

  Defined as the number of eligible participants who consent to participate in the trial as a percentage of all eligible participants. This will be presented per centre per month and measured over the recruitment period (from randomisation of the first participant to randomisation of the 50th participant). The target recruitment rate is defined as recruitment of 50 participants from three recruiting centres, with each centre being open to recruitment for 12 months. This produces a mean trial target recruitment rate of 1.4 participants per centre per month.

  18 months

• Retention rate

  Defined as the proportion of randomised participants who complete 6-week follow-up with valid candidate clinical outcomes data. Barriers and facilitators to recruitment and retention among participants and recruitment site staff (anaesthetists, allied health professionals, surgeons and research staff). This will be assessed in the embedded qualitative study.

  18 months

• Qualitative feedback

  Qualitative research will be embedded within the ESPEAR RCT feasibility trial to provide insights into the feasibility and design of a main RCT trial. It will focus on two key aspects: Understanding the acceptability and feasibility of delivering the intervention/control in practice Exploring patients' experience of trial participation and acceptability of interventions The aim of this qualitative work is to enrich the quantitative data collected. The qualitative study intends to provide insight into processes used for research delivery and highlight where these processes vary between centres. Identification of barriers to recruitment will facilitate improvements in trial design should this feasibility trial proceed to a full trial. The trial will use multiple approaches to qualitative data-collection to optimize data collection.

  18 months

Secondary Outcomes (6)

• Screening rate

  18 months

• Eligibility rate

  18 months

• Consent rate

  18 months

• Protocol violations

  2 years

• Trial withdrawals

  2 years

Study Arms (2)

ESP Block

ACTIVE COMPARATOR

ESP Block

Procedure: ESP Block

Placebo

PLACEBO COMPARATOR

Placebo

Procedure: ESP Block

Interventions

ESP Block PROCEDURE

ESP block

ESP Block; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 Mechanism of injury blunt thoracic trauma Radiographic evidence of 1 or more new traumatic rib fractures Moderate or severe unilateral acute pain (defined as 11-point numerical rating scale (NRS) pain \>4 when patient performing vital capacity breath or effective cough) at time of enrolment. Patients may have bilateral fractures, but pain must be unilateral.

You may not qualify if:

• Patient refusal or inability to give informed written consent for any reason Thoracic injury requiring emergent operative or interventional radiology management Allergy to local anaesthetic Infection at site of ESP block Actual or estimated

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (3)

Barts Health NHS Trust

London, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Queens Medical Centre

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only anesthetist will be un blinded. Research nurse and participant will be blinded to treatment arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: March 27, 2026
• Study Start: July 1, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)