NCT01513564

Brief Summary

Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery. The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.9 years

First QC Date

December 13, 2011

Last Update Submit

May 27, 2015

Conditions

Degenerative Spondylolisthesis

Keywords

Disc diseaseSpondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Multimodal management of lumbar fusion

    Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index

    Two years

Secondary Outcomes (1)

  • Multimodal management of lumbar fusion

    Two years

Study Arms (1)

Conservative treatment program

EXPERIMENTAL

The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed. The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program.

Drug: Postoperative epidural morphineDrug: Local anaesthesia

Interventions

Postoperative epidural morphineDRUG

The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.

Also known as: Convalescence after lumbar fusion
Conservative treatment program
Local anaesthesiaDRUG

Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.

Also known as: Convalescence after lumbar fusion.
Conservative treatment program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.

You may not qualify if:

  • Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Research Unit, Aarhus University, Aalborg Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Spondylolisthesis

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Sten Rasmussen, M.D.

    Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • David S. Krum-Moeller, M.D.

    Department of Orthopaedic Surgery, Vejle and Give Hospital

    STUDY CHAIR

  • Lene R. Lauridsen

    Department of Orthopaedic Surgery, Vejle and Give Hospital

    STUDY CHAIR

  • Henrik Kehlet, M.D.

    Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

January 20, 2012

Study Start

January 1, 2001

Primary Completion

December 1, 2003

Study Completion

June 1, 2006

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DK(1)