NCT01489631

Brief Summary

Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome. Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

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

First Submitted

Initial submission to the registry

December 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.1 years

First QC Date

December 8, 2011

Last Update Submit

June 4, 2015

Conditions

Total Knee Arthroplasty

Keywords

EpiduralLocal infiltrationKneeArthroplasty

Outcome Measures

Primary Outcomes (1)

  • NRS score in rest

    3 days after surgery

Secondary Outcomes (4)

  • Speed of mobilisation

    3 days after surgery

  • Postoperative morphine consumption

    3 days after surgery

  • NRS score during flexion exercise

    3 days after surgery

  • NRS score during walking exercise

    3 days after surgery

Study Arms (3)

epidural analgesia

ACTIVE COMPARATOR

The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.

Drug: marcaineDrug: sufentanil

local infiltration

ACTIVE COMPARATOR

The second group will receive local infiltration with ropivacaine of the knee during surgery.

Drug: naropin

local infiltration and gabapentin

ACTIVE COMPARATOR

The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.

Drug: naropinDrug: neurontin

Interventions

naropinDRUG

ropivacaine 0,2%, 3x 50 ml during surgery

Also known as: ropivacaine
local infiltrationlocal infiltration and gabapentin
marcaineDRUG

bupivacaine 0,125%

Also known as: bupivacaine
epidural analgesia
sufentanilDRUG

sufentanil 1mcg/ml

Also known as: sufenta forte
epidural analgesia
neurontinDRUG

gabapentin 600 mg pre-operative 3 dd 300 mg

Also known as: gabapentin
local infiltration and gabapentin

Eligibility Criteria

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

You may qualify if:

  • years or older and legally responsible
  • Waiting for total knee replacement surgery
  • Informed consent

You may not qualify if:

  • Contraindications for epidural analgesia
  • Aortic Valve stenosis
  • Severely compromised cardiac function
  • infection near epidural punction site
  • Redo knee surgery
  • Previous arthrotomies
  • Allergy/Hypersensitivity for study mediation or all other used medication
  • Participation in other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

Location

MeSH Terms

Interventions

RopivacaineBupivacaineSufentanilGabapentin

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Leon Timmerman, MD

    Anesthesiologist

    PRINCIPAL INVESTIGATOR

  • Louis N Marting, MD

    Orthopedic surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiologist

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 9, 2011

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

NL(1)