Analgesia After Total Knee Replacement Surgery

St. Antonius Hospital

Status: Completed

Conditions: Total Knee Arthroplasty

Treatments: Drug: naropin; Drug: marcaine; Drug: neurontin; Drug: sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01489631

TKP-37796

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

epidural analgesia

Active Comparator group

Description:

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.

Treatment:

Drug: sufentanil

Drug: marcaine

local infiltration

Active Comparator group

Description:

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

Treatment:

Drug: naropin

local infiltration and gabapentin

Active Comparator group

Description:

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

Treatment:

Drug: neurontin

Drug: naropin