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Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain

Not Applicable
Recruiting
Conditions
Post-thoracotomy Pain Syndrome
Interventions
Procedure: Erector spinae plane block
Procedure: erector spinae plane block + retrolaminar block
Registration Number
NCT05791539
Lead Sponsor
Cairo University
Brief Summary

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain

Detailed Description

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality.

The surgical incision produces post-thoracotomy pain (PTP) via damage to the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits the ability to breathe and cough normally. Numerous analgesic techniques are used to relieve PTP, including systemic opioids, regional techniques (such as paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous electrical nerve stimulation (TENS).

Emerging research has shown that the novel erector spinae plane block (ESPB) can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults.

ESPB was first reported in 2016 for ipsilateral thoracic analgesia. It was found to be a safe and effective block that can be performed by an emergency physician in the emergency department setting for addressing acute pain due to multiple rib fractures.

Retrolaminar block (RLB) was first reported in 2006 as an alternative approach to PVB. RLB is performed with US imaging or the landmark technique. The efficacy of continuous RLB has been reported for breast cancer surgery .

However, the efficacy of ESPB has been described in a greater number of clinical reports than has RLB: a rib fracture, breast surgery, thoracoscopic surgery, lumbar spinal surgery, and laparoscopic abdominal surgery. In contrast to RLB, most of the literature on ESPB reported the use of the single-shot technique (80.2%). The local anesthetic was postulated to infiltrate the ventral and dorsal rami of the spinal nerve. However, Ueshima et al. reported that ESPB could not provide adequate analgesia of the anterior branch of the intercostal nerve.

The rationale of the study is that to the best of our knowledge each of ESPB and RLB has limitations regarding sensory block and distribution so our hypothesis is combining both will provide more solid block regarding sensory distribution, time interval of the block efficacy, and postoperative morphine consumption in patients undergoing thoracic surgeries.

Few studies evaluated the efficacy of ultrasound (US) guided erector spinae plane block on post-thoracotomy analgesia, however for the best of our knowledge no one compared the effect of ultrasound (US) guided retrolaminar block combined with erector spinae plane block and ultrasound (US) guided erector spinae plane block alone in patients undergoing thoracic surgeries.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
32
Inclusion Criteria
    1. Inclusion criteria
    • Age from 18-65 years.
    • body mass index (BMI) ranged between 20 and 40 kg/m2
    • ASA I, II patients undergoing open thoracic surgery through a posterolateral thoracotomy 2. Exclusion criteria
    • Patient refusal.
    • Sensitivity or contraindication to local anesthetic drugs.
    • History of psychological disorders and/or chronic pain.
    • Localized infection at the site of the block.
    • Coagulopathies, patients on anticoagulants and antiplatelets, and significant liver or renal insufficiency
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 2: Erector spinae plane blockErector spinae plane blockUS-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side.
Retro laminar blockerector spinae plane block + retrolaminar blockthe US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side.
Group 1 Erector spinae plane blockErector spinae plane blockGroup 1 (ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB on the operated side by 20 ml bupivacaine 0.25%.
Primary Outcome Measures
NameTimeMethod
Total amount of morphine consumption in the first 24-hour postoperative in the two groups.24 hours

20ml for ESPB compared to 10ml ESPB added to 10ml RLB.

Secondary Outcome Measures
NameTimeMethod
.First request of analgesia postoperative24 hours

first time to request analgesia in the first 24 hrs

Incidence of complications24 hours

•Incidence of complications as hypotension, bradycardia, postoperative nausea, vomiting (PONV) and pruritis.

MAPintraoperative

Mean arterial blood pressure in mmhg at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.

•Pain score according to VAS score24 hours

Pain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h postoperative.

• Heart rateintraoperative

• Heart rate(Bpm) at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.

Trial Locations

Locations (1)

Cairo Unviersity

🇪🇬

Cairo, Egypt

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