NCT03300089

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

September 27, 2017

Last Update Submit

September 27, 2017

Conditions

Herniated Disk Lumbar

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Cumulated morphine consumption in mg

    From immediately after the operation until 48 hours postoperative

Secondary Outcomes (2)

  • VAS score

    Postoperative at the day of surgery until 48 hours postoperative

  • Anesthesia time

    Day of surgery

Study Arms (2)

General Anaesthesia

ACTIVE COMPARATOR

General Anaesthesia during surgery

Procedure: General anaesthesia

Regional Anaesthesia

EXPERIMENTAL

Regional Anaesthesia during surgery

Procedure: Regional anaesthesia

Interventions

General anaesthesiaPROCEDURE

General anaesthesia

General Anaesthesia
Regional anaesthesiaPROCEDURE

Regional anaesthesia

Regional Anaesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Anna Hospital

Lucerne, CH - 6006, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 24635923BACKGROUND

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Bertram Bänziger, MD

    Klinik St. Anna Luzern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor and statistician are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 3, 2017

Study Start

January 19, 2016

Primary Completion

May 30, 2017

Study Completion

July 20, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

CH(1)