Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06233617
Other study ID # 3/2024
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Poznan University of Medical Sciences
Contact Malgorzata Domagalska, PhD
Phone +48 61 873 83 03
Email m.domagalska@icloud.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery.


Description:

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery. After spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. The safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect. There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - patients undergoing primary posterior lumbar decompression and stabilization with instrumentation involving multi-levels in the lumbar region, - aged >18 years and <100 years - ASA physical status 1, 2 or 3. Exclusion Criteria: - refuse to participate, - history of opioid abuse, - infection of the puncture site, - aged <18 years and >100 years - ASA 4 and 5

Study Design


Intervention

Drug:
0.9% Sodium Chloride Injection
biliteral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block
Dexamethasone 4 Mg/mL Injectable Solution
biliteral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block
Dexmedetomidine injection
biliteral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block

Locations

Country Name City State
Poland Poznan University of Medical Sciences Poznan Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary first need of opiate Time after surgery when the patient needs opiate for the first time 48 hours
Secondary Opioid consumption Total opiate consumption after surgery 48 hours
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 4 hours after surgery
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 8 hours after surgery
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 12 hours after surgery
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 16 hours after surgery
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 20 hours after surgery
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) Time Frame: 24 hours after surgery
Secondary NLR Neutrophil-to-lymphocyte ratio 48 hours after surgery
Secondary PLR Platelet-to-lymphocyte ratio 48 hours after surgery
See also
  Status Clinical Trial Phase
Completed NCT06290908 - RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
Withdrawn NCT03223701 - Efficacy of Using Solum IV and BMC With GFC in TLIF Phase 4
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Completed NCT02902380 - The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery N/A
Not yet recruiting NCT06024785 - Vertebropexy - Randomized-controlled Trial N/A
Not yet recruiting NCT06000319 - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Completed NCT02454400 - Pre-surgery Physiotherapy for Patients With Specific Low Back Pain N/A
Completed NCT01377623 - Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion N/A
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Completed NCT00996073 - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion Phase 2
Completed NCT00320619 - Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery N/A
Completed NCT00022776 - Surgical Versus Nonsurgical Treatment for Spinal Stenosis Phase 3
Completed NCT06060821 - Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
Recruiting NCT04552145 - Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis N/A
Active, not recruiting NCT04379921 - Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch N/A
Withdrawn NCT04315090 - Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Completed NCT04591249 - Physical Activity Intervention for Patients Following Lumbar Spine Surgery N/A
Recruiting NCT04601363 - Personalized Spine Study Group (PSSG) Registry
Completed NCT04193488 - Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery N/A