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OpenTrials
Completed

NCT Number: NCT01489631

Analgesia After Total Knee Replacement Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

About this study

Study design:

Prospective randomised study

Study population:

Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.

Intervention:

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. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.

Primary study parameters/outcome of the study:

NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.

Secondary study parameters/outcome of the study:

Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

naropin

Drug

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

Other names: ropivacaine

marcaine

Drug

bupivacaine 0,125%

Other names: bupivacaine

Sufentanil

Drug

sufentanil 1mcg/ml

Other names: sufenta forte

neurontin

Drug

gabapentin 600 mg pre-operative 3 dd 300 mg

Other names: gabapentin

Primary outcomes

  1. NRS score in rest

    Time frame: 3 days after surgery

Secondary outcomes

  1. Speed of mobilisation

    Time frame: 3 days after surgery

  2. Postoperative morphine consumption

    Time frame: 3 days after surgery

    Daily morphine consumption (mg) per day

  3. NRS score during flexion exercise

    Time frame: 3 days after surgery

  4. NRS score during walking exercise

    Time frame: 3 days after surgery

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2011
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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