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

NCT ID: NCT05791539

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-11-30

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.

Conditions

Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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%.

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: PROCEDURE

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.

Group 2: Erector spinae plane block

US-guided ESPB with 10 ml bupivacaine 0.25% (n = 15) on the operated side.

Group Type: EXPERIMENTAL

Erector spinae plane block

Intervention Type: PROCEDURE

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.

Retro laminar block

the US-guided retrolaminar block 10 ml bupivacaine 0.25% group: (n = 15) on the operated side.

Group Type: EXPERIMENTAL

erector spinae plane block + retrolaminar block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age from 18-65 years.
• body mass index (BMI) ranged between 20 and 40 kg/m2

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

sherif Mamdouh Abbas

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sherif mamdouh, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo Unviersity

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

sherif mamdouh, MD

Role: CONTACT

s25041989@hotmail.com

01141235049 ext. 002

Facility Contacts

Sherif M Abbas, MD

Role: primary

s25041989@hotmail.com

0201141235049 ext. 002

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MS-397-2022

Identifier Type: -

Identifier Source: org_study_id