Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration

Status Completed

Clinical Trial Summary

Postoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient. In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects. In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital. The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration. The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04123106
Study type	Interventional
Source	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status	Completed
Phase	N/A
Start date	May 11, 2020
Completion date	September 28, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05480111` - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy	Phase 4
Completed	`NCT06129305` - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed	`NCT04401826` - Micro-surgical Treatment of Gummy Smile	N/A
Recruiting	`NCT04020133` - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.	N/A
Completed	`NCT03023462` - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair	N/A
Completed	`NCT03546738` - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery	N/A
Completed	`NCT03652103` - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy	Phase 4
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Terminated	`NCT03261193` - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain	Phase 3
Completed	`NCT02525133` - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Phase 3
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Enrolling by invitation	`NCT05316168` - Post Operative Pain Management for ACL Reconstruction	Phase 3
Recruiting	`NCT04130464` - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management	Phase 4
Enrolling by invitation	`NCT04574791` - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty	N/A
Completed	`NCT04526236` - Influence of Aging on Perioperative Methadone Dosing	Phase 4
Completed	`NCT04073069` - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults	Phase 4
Recruiting	`NCT05351229` - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery	Phase 4
Enrolling by invitation	`NCT05543109` - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block	N/A
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04919317` - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms