Herniated Disk LumbarNCT03300089
Lumbar Spine Surgery: Regional vs. General Anaesthesia
A study testing General anaesthesia and Regional anaesthesia in people with Herniated Disk Lumbar, run by St. Anna Clinic Luzern at 1 site in Switzerland.
Trial summary
Background: Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have different side effect profiles (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniated Disk Lumbar
- What is being tested?
- General anaesthesia and Regional anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2016to 20 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must give informed consent before registration.
- 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
Who cannot join
- ASA ≥ 4
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anaesthetic Techniques on Clinical Outcome After Lumbar Spine Surgery: Regional Versus General Anaesthesia. A Prospective Randomized Controlled Trial
Background: Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may affect quality of recovery in different ways.
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.
Read more
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.
Read the detailed description
- Background Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA). In a recent review several studies showed a decreased postoperative pain score in the RA groups (1). But only few randomized control trials (RCT) have been performed comparing these two anaesthetic techniques and have shown partly conflicting results (2-5). 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).
- 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.
- 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
- Herniated Disk Lumbar
- Being tested
- General anaesthesia, Regional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesiaProcedure or surgery
General anaesthesia
Regional anaesthesiaProcedure or surgery
Regional anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | Active comparator | General Anaesthesia during surgery Receives: Procedure: General anaesthesia |
| Regional Anaesthesia | Experimental | Regional Anaesthesia during surgery Receives: Procedure: Regional anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Cumulated morphine consumption in mg
Measured: From immediately after the operation until 48 hours postoperative
Secondary outcomes (2)
VAS score
Visual Analog Pain assessment, assessed each day
Measured: Postoperative at the day of surgery until 48 hours postoperative
Anesthesia time
Duration of anesthesia in minutes
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start19 Jan 2016
- Primary completion30 May 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herniated Disk LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anna Clinic Luzern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertram Bänziger, MD, Principal investigator, Klinik St. Anna Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300089
- Sponsor's protocol ID
- EKNZ 2015-261
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24635923
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anaesthetic Techniques on Clinical Outcome After Lumbar Spine Surgery: Regional Versus General Anaesthesia. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03300089
- Acronym / sponsor ID
- EKNZ 2015-261
- Conditions
- Herniated Disk Lumbar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Anna Clinic LuzernUniversity, hospital or other
- Study start
- 19 Jan 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may affect quality of recovery in different ways.
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
- Background Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA). In a recent review several studies showed a decreased postoperative pain score in the RA groups (1). But only few randomized control trials (RCT) have been performed comparing these two anaesthetic techniques and have shown partly conflicting results (2-5). 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).
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | Active comparator | Procedure: General anaesthesiaGeneral Anaesthesia during surgery |
| Regional Anaesthesia | Experimental | Procedure: Regional anaesthesiaRegional Anaesthesia during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must give informed consent before registration.
- 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
Key exclusion criteria (8 listed)
- ASA ≥ 4
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anaesthesiaGeneral anaesthesia | Procedure or surgery | General Anaesthesia |
| Regional anaesthesiaRegional anaesthesia | Procedure or surgery | Regional Anaesthesia |
Primary outcome
Morphine consumption
Time frame: From immediately after the operation until 48 hours postoperative
Cumulated morphine consumption in mg
2 secondary outcomes
VAS score
Time frame: Postoperative at the day of surgery until 48 hours postoperative
Anesthesia time
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Background: PubMed 24635923De 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertram Bänziger, MD principal investigator
Klinik St. Anna Luzern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anaesthesia and Regional anaesthesia in people with Herniated Disk Lumbar, run by St. Anna Clinic Luzern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: From immediately after the operation until 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03300089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017; AzTrials last refreshed its copy on 2 Nov 2026.