Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2016-01-19
2017-07-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Aim of the study: The purpose of this study is to determine the effects of GA and RA in lumbar spine surgery on clinical outcome, combining validated patient-reporting instruments and morbidity such as serious adverse events.
Hypothesis: The investigators hypothesize that in patients undergoing lumbar spine surgery, RA shows significant advantages as compared to GA with respect to the postoperative pain score, the degree of postoperative nausea and vomiting (PONV), the postoperative anaesthetic care unit (PACU) and anaesthesia time and the satisfaction of patients and surgeons.
Design of the study: This is a single-centre two-arm randomised-controlled trail.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each anaesthetic agent or regimen has a particular side effect profile (e.g. opioids - nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may affect quality of recovery in different ways. Although there are few data examining the correlation between side effects from different analgesic regimens and quality of recovery per se, some data suggest different analgesic regimens will result in different side effects and consequently different levels of quality of recovery.
Although inconsistent data exist covering surgery time, anaesthesia time, postoperative anaesthetic care unit (PACU) time and postoperative analgesic dose requirements (6-8).
But there are some hinds that RA leads to better results concerning postoperative mortality and morbidity in opposite to general anaesthesia (9-10). Also RA showed better results concerning economic aspects (11,12).
No clinical trials have sufficient subject numbers to determine definitively the effects of anaesthetic techniques on minor or major benefits concerning clinical outcome. There is insufficient evidence to confirm or deny the ability of these two anaesthetic techniques to affect major postoperative mortality or morbidity and there is currently no sufficient evidence that RA or GA have any clinically significant beneficial effect on postoperative outcome. Further there are still insufficient data to determine if the type of anaesthetic technique, degree of analgesia and the presence of side effects may influence quality of life, quality of recovery, patient and surgeon's satisfaction and length of hospitalisation.
There are few data examining the correlation between side effects from different anaesthetic regimens and quality of recovery per se, some data suggest different analgesic regimens may result in different side effects and consequently different levels of quality of recovery.
Although there are data suggesting that improved postoperative analgesia leads to better patient outcomes, there is insufficient evidence to support subsequent improvements inpatient-centered outcomes such as quality of life and quality of recovery. So the correlation between RA and different outcome parameters are very complex and up to now there is no clear evidence for any recommendation concerning the use of RA or GA in generally (13).
2. Study Objective Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA). The purpose of this study is to determine the effects of two different anaesthetic techniques and their impact on clinical outcome.
Further this study is developed to combine validated patient-reported instruments with the assessment of the effect of different anaesthetic techniques on patient-reported outcomes in the peri-and postoperative period.
3. Hypothesis The investigators hypothesize that for patients undergoing lumbar spine surgery, the performing of a RA shows significant benefits in comparison with patients receiving GA. It concerns the postoperative pain score, the degree of PONV, the PACU and anaesthesia time and the patient's and surgeons's satisfaction.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
General Anaesthesia
General Anaesthesia during surgery
General anaesthesia
General anaesthesia
Regional Anaesthesia
Regional Anaesthesia during surgery
Regional anaesthesia
Regional anaesthesia
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
General anaesthesia
General anaesthesia
Regional anaesthesia
Regional anaesthesia
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years
* Physical Status Classification of the American Society of Anaesthesiologists Score (ASA) ≤ 3
* Patient with a diagnosed lumbar spinal stenosis or a herniated lumbar disc for elective neurosurgery
Exclusion Criteria
* Infection at the site of the operation field
* Longterm History (≥ 6 month) of neuropathic pain on the operation site
* Revision surgery and/or follow-up operations
* Severe coagulopathy (platelet count \< 100.000 / mL3 or Thromboplastin time \< 50%)
* Allergy to local anaesthetics or opioids
* Previous drug dependency or chronic use of opioids (≥ 6 month)
* Psychiatric disorder precluding understanding of information on trial related topics or given informant consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
St. Anna Clinic Luzern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bertram Bänziger, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik St. Anna Luzern
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Anna Hospital
Lucerne, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
De Rojas JO, Syre P, Welch WC. Regional anesthesia versus general anesthesia for surgery on the lumbar spine: a review of the modern literature. Clin Neurol Neurosurg. 2014 Apr;119:39-43. doi: 10.1016/j.clineuro.2014.01.016. Epub 2014 Jan 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EKNZ 2015-261
Identifier Type: -
Identifier Source: org_study_id