Clinical trial NCT01489631: Analgesia After Total Knee Replacement Surgery
Official title: Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Epidural
Local infiltration
Knee
Arthroplasty
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS score in rest
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Speed of mobilisation
timeFrame: 3 days after surgery
measure: Postoperative morphine consumption
timeFrame: 3 days after surgery
measure: NRS score during flexion exercise
timeFrame: 3 days after surgery
measure: NRS score during walking exercise
timeFrame: 3 days after surgery
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Anesthesiologist
name: Leon Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic surgeon
name: Louis N Marting, MD
role: PRINCIPAL_INVESTIGATOR
References: