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

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

Study Overview

• Status: Recruiting
• Conditions: Post-thoracotomy Pain Syndrome
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: erector spinae plane block + retrolaminar block

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sherif mamdouh, MD; Phone Number: 002 01141235049; Email: s25041989@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo Unviersity
    • Contact: Sherif M Abbas, MD; Phone Number: 002 0201141235049; Email: s25041989@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Erector spinae plane block; Group 1 (ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB on the operated side by 20 ml bupivacaine 0.25%.	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.
Experimental: Group 2: Erector spinae plane block; US-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side.	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.
Experimental: Retro laminar block; the US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
•Pain score according to VAS score	Pain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h postoperative.	24 hours
• Heart rate	• Heart rate(Bpm) at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.	intraoperative
Incidence of complications	•Incidence of complications as hypotension, bradycardia, postoperative nausea, vomiting (PONV) and pruritis.	24 hours
.First request of analgesia postoperative	first time to request analgesia in the first 24 hrs	24 hours
MAP	Mean arterial blood pressure in mmhg at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then every 1h intraoperative.	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: sherif mamdouh, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): October 12, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MS-397-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No