Clinical Trials Logo

Clinical Trial Summary

The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.


Clinical Trial Description

Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than 15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be administered intravenously every 5 minutes until SPI value decreases to basic level calculated previously before operation started.

Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.

In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02971540
Study type Interventional
Source Medical University of Silesia
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date July 30, 2017

See also
  Status Clinical Trial Phase
Completed NCT01941563 - A Study of SI-6603 in Patients With Lumbar Disc Herniation Phase 3
Completed NCT04061759 - Physiotherapy in Lumbar Disc Pathologies N/A
Recruiting NCT04727385 - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease N/A
Completed NCT04587401 - The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure N/A
Not yet recruiting NCT06034041 - The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study Phase 4
Recruiting NCT04134975 - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study N/A
Recruiting NCT05146583 - Injection of Autologous Bone Marrow Aspirate in Patients With Degenerative Disc Disease.
Recruiting NCT04641039 - Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis N/A
Completed NCT04301232 - Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
Recruiting NCT06154005 - OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion Phase 1/Phase 2
Completed NCT03977961 - The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
Enrolling by invitation NCT05444751 - GA + ESP vs. SA + ESP in Lumbar Decompression Surgeries Phase 3
Completed NCT02700451 - Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes N/A
Completed NCT02421601 - A Study of SI-6603 in Patients With Lumbar Disc Herniation Phase 3
Active, not recruiting NCT03733626 - Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease N/A
Recruiting NCT04042844 - A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD) Phase 2
Recruiting NCT06462729 - LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) Phase 1/Phase 2
Completed NCT05345249 - Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery Phase 4
Active, not recruiting NCT03060434 - Pentoxifylline and Lumbar Radiculopathy Phase 4
Withdrawn NCT02852187 - Single Center Study Comparing MOBIS II ST vs MOBIS PEEK N/A