ESP Block Versus Wound Infiltration for Laminectomy

Study Overview
=================
Brief Summary
-----------------
Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy

Official Title
-----------------
ESP Block Versus Wound Infiltration for Laminectomy: a Randomized Controlled Trial

Conditions
-----------------
Pain, Postoperative, Opioid Use, Anesthesia, Local, Surgery

Intervention / Treatment
-----------------
* Drug: ESP block with saline
* Drug: Wound infiltration with saline
* Drug: ESP block with local anesthetic
* Drug: Wound infiltration with local anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Planned 1 or 2 level surgical laminectomy Exclusion Criteria: Allergy to local anesthetics Refusal of consent Uncompensated cardiopathies, nephropathies, liver disease or peripheral neuropathies Hemopathies that predispose to bleeding Gastrointestinal ulcer or bleeding Local infection Psychiatric or neurological disorders (except those attributed to primary disease for which intervention is planned) History of abuse (or use in the 24 hours prior to surgery) Alcohol addiction ASA > 3

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP block<br>Patient will receive ESP block one level above surgery with ropivacaine 0.35% 20 ml per side Patient will receive preoperative wound infiltration with Saline 40 ml | Drug: Wound infiltration with saline<br>* Blinded injection of saline in the skin, subcutaneous tissue and muscles at the site of surgical incision<br>Drug: ESP block with local anesthetic<br>* Bilateral ultrasound guided injection of local anesthetic (ropivacaine 0.35%, 40ml) in the erector spinae plane (below erector spinae plane muscle group and above the tranverse process of the vertebra)<br>* Other names: Erector spinae plane block;|
| Active Comparator: Wound infiltration<br>Patient will receive ESP block one level above surgery with Saline 20 ml per side Patient will receive preoperative wound infiltration with ropivacaine 0.35% 40 ml | Drug: ESP block with saline<br>* Bilateral ultrasound guided injection of saline in the erector spinae plane (below erector spinae plane muscle group and above the transverse process of the vertebra)<br>* Other names: Erector spinae plane block;Drug: Wound infiltration with local anesthetic<br>* Blinded injection of local anestetic (ropivacaine 0.35%, 40ml) in the skin, subcutaneous tissue and muscles at the site of surgical incision.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tramadol consumption | Postoperative tramadol consumption | Evaluated from extubation for the first post-operative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 0 hours | Pain measured with Numeric Rating Scale (0-10) | At extubation | 
| Pain 6 hours | Pain measured with Numeric Rating Scale (0-10) | 6 hours after end of surgery | 
| Pain 12 hours | Pain measured with Numeric Rating Scale (0-10) | 12 hours after end of surgery | 
| Pain 24 hours | Pain measured with Numeric Rating Scale (0-10) | 24 hours after end of surgery | 
| Time to first analgesic requirement | Time in minutes to first analgesic requirement | 24 hours after end of surgery | 
| Incidence of post operative nausea-vomiting | Incidence of post operative nausea-vomiting | 24 hours after end of surgery | 
| Incidence of post operative respiratory depression | Incidence of post operative respiratory depression | 24 hours after end of surgery | 
| Incidence of post operative pruritus | Incidence of post operative pruritus | 24 hours after end of surgery | 
| Incidence of post operative motor block | Incidence of post operative motor block | 24 hours after end of surgery | 
| Intraoperative opioid consumption | Intraoperative difference in consumption of fentanyl. | At extubation | 
| Evaluation of patient satisfaction | Evaluation of patient satisfaction of analgesia on a numeric rating score from 0-10. | 24 hours after end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESP block, Laminectomy, Wound infiltration