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Erector Spinae Plane Block for Post-thoracotomy Pain Control

The Impact of Ultrasound-Guided Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in the Management of Acute and Chronic Post-Thoracotomy Pain: A Randomized, Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04531553
Enrollment
90
Registered
2020-08-28
Start date
2021-03-03
Completion date
2022-06-15
Last updated
2022-08-02

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

Conditions

Post-thoracotomy Pain Syndrome

Brief summary

The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

Detailed description

The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery. However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and TPVB has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain. ESPB is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade. The selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. Accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. Previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route. This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

Interventions

PROCEDUREThoracic epidural analgesia

Patients will preoperatively receive thoracic epidural at the level T5 & T6 with bolus 20 ml of levobupivacaine 0.25% then levobupivacaine 0.1% infused at a rate of 0.1 mL/Kg/hr until chest tube removal ( 5-6 days).

PROCEDUREESPB with levobupivacaine and dexmedetomedine

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% plus 0.5mic/Kg dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted. 20 ml bolus of levobupivacaine 0.1% with dexmedetomidine 0.5 μg/Kg was injected every 6 hours until chest tube removal.

PROCEDUREESPB with levobupivacaine

patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of levobupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted.A 20 ml bolus of levobupivacaine 0.1% is injected every 6 hours until chest tube removal.

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Physical status ASA I and II. * Age ≥ 18 and ≤ 65 Years. * Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2. * Patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).

Exclusion criteria

* Patient refusal * Known sensitivity or contraindication to local anesthetics or dexmedetomidine. * History of psychological disorders. * Localized infection at the site of block. * Coagulopathies with platelet count below 50,000 or an INR\>1.5.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity score1 weekmeasurement of Visual analogue score in a line 0 to 100 , where 0 indicates no pain and 100 indicates the worst pain.

Secondary

MeasureTime frameDescription
Number of patients who will develop post-thoracotomy pain syndrome.3 monthsReporting the emergence of post-thoracotomy pain syndrome in all the studied patients.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026