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

Post-thoracotomy Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791539
• Other study ID #: MS-397-2022
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: sherif mamdouh, MD
• Phone: 01141235049
• Email: s25041989[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-thoracotomy Pain Syndrome

Intervention

Procedure:
• Erector spinae plane block
Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.
• erector spinae plane block + retrolaminar block
Patients will be divided into 2 groups group 1 will receive US-guided ESPB and group 2 will receive US-guided ESPB + US-guided Retrolaminar plain block before induction of GA.

Locations

Country	Name	City	State
Egypt	Cairo Unviersity	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of morphine consumption in the first 24-hour postoperative in the two groups.	20ml for ESPB compared to 10ml ESPB added to 10ml RLB.	24 hours
Secondary	•Pain score according to VAS score	Pain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h postoperative.	24 hours
Secondary	• Heart rate	• Heart rate(Bpm) at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.	intraoperative
Secondary	Incidence of complications	•Incidence of complications as hypotension, bradycardia, postoperative nausea, vomiting (PONV) and pruritis.	24 hours
Secondary	.First request of analgesia postoperative	first time to request analgesia in the first 24 hrs	24 hours
Secondary	MAP	Mean arterial blood pressure in mmhg at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.	intraoperative