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A Double-Blinded, Randomized, Controlled Trial to Test the Efficacy of Continuous Ultrasound Guided Erector Spinae Block on Lung Function for Rib Fracture Related Pain

A Double-Blinded, Randomized, Controlled Trial to Test the Efficacy of Continuous Ultrasound Guided Erector Spinae Block on Respiratory Function for Rib Fracture Related Pain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000080921
Enrollment
60
Registered
2020-01-30
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rib fractures are common injuries and can result in significant morbidity and mortality. Among the common regional anaesthetic techniques to treat rib fracture and related acute pain are thoracic epidurals and paravertebral catheters which are technically challenging and pose potentially serious harms. In recent years, the Erector Spinae Plane block has been used for our rib fracture patients at the Alfred and the aim of this study is to test whether continuous erector spinae plane catheter improves lung function in patients with more than 3 contigous rib fractures before and at various time points after implementation of ESP blockade.

Interventions

Arm 1: The interventional treatment arm group consisting of 30 patients will have an ultrasound guided continuous erector spinae plane (ESP) catheter placed at the midpoint vertebral level of the affected fractured rib. A high linear (or curvilinear probe in morbidly obese patients) frequency transducer will be held in a parasagittal plane at the centre of the pain source. Next, the transverse process at the vertebral level of the middle fractured rib will be identified with the overlying erecto

Arm 1: The interventional treatment arm group consisting of 30 patients will have an ultrasound guided continuous erector spinae plane (ESP) catheter placed at the midpoint vertebral level of the affected fractured rib. A high linear (or curvilinear probe in morbidly obese patients) frequency transducer will be held in a parasagittal plane at the centre of the pain source. Next, the transverse process at the vertebral level of the middle fractured rib will be identified with the overlying erector spinae muscle. Other important sonoanatomical landmarks are the skin, subcutaneous tissue, trapezius muscle and the rhomboid muscle, which tapers off below the T5/6 region. Under strict aseptic conditions, an E-Catheter plus 20G with stylet and 15mm extended tip / indwelling cannula 18G x 75mm (3") / SonoPlex 21G x 94mm (3 2/3") will be directed from the short edge of the ultrasound probe either in a cranio-caudal direction or caudo-cranial direction depending on logistics and fracture location into the erector spinae plane, which is the fascial plane between the anterior border of the erector spinae muscle that abut the posterior margin of the relevant transverse process. Once contact to bone is established both in a tactile fashion as well as visible on live imaging. A bolus dose of 0.35 mls/kg of 0.5% Ropivacaine will be injected into the plane and the successful endpoint in proper needle positioning will be a lifting off the erector spinae muscle from the transverse process.The continuous erector spinae block will be maintained with strict programmable bolus dosing of 20 mls of 0.2% Ropivaine every 4 hours for 24 hrs. In addition, breakthrough pain will be treated with systemic opioids via patient controlled analgesia (PCA) + regular Paracetamol Arm 2: The control group will have a catheter placed into the exact same method and into the same myofascial compartment as the study group, with the only difference being, that placebo (normal saline) shall be injected into the plane with the exact same volume and under the exact same regime as in the study group. The ESP catheter will be inserted by a dedicated group of anesthesiologists with extensive experience in regional anaesthesia and analgesia single shot and continous catheter techniques " Under strict aseptic conditions, an 18 G indwelling catheter x 75 mm ( with a 21 G x 94 mm SonoPlex cannula) will be directed from the short edge of the ultrasound probe either in a cranio-caudal direction or caudo-cranial direction depending on logistics and fracture location into the erector spinae plane, which is the fascial plane between the anterior border of the erector spinae muscle that abut the posterior margin of the relevant transverse process. A bolus of 0.35 ml/kg of 0.5% Ropivacaine will be injected into the plane and the successful endpoint in proper needle positioning will be a lifting off the erector spinae muscle from the transverse process. The Sonoplex cannula will be removed and an 18 G x 75 mm E- Cath Plus will be inserted via the indwelling cannula at a predefined length (15 mm protruding tip of E-Cath past the indwelling cannula).

Sponsors

Australian and New Zealand College of Anaesthetists
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged above the age of 18 3 or more unilateral contiguous rib fractures, Blunt Chest Trauma, Lung contusions, flail chest Patients who are deemed to be eligible for a regional continuous catheter technique by the treating lead physician of the Acute Pain Service Patients able to communicate pain scores

Exclusion criteria

Bilateral Chest Trauma Intubated Patients Traumatic Brain Injury, altered mental status, impaired ability to complete questionnaires or communicate Sensitivity to local anaesthetic drugs Infection or Tumour at the site of procedure Coagulaopathy Pregnancy Healthy Volunteers Admission to hospital for more than 72 hours Any previous form of regional anesthesia performed on the Patient History of chronic pain/chronic opioid therapy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026