Analgesia After Total Knee Replacement Surgery

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489631
• Other study ID #: TKP-37796
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: June 4, 2015
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• naropin
ropivacaine 0,2%, 3x 50 ml during surgery
• marcaine
bupivacaine 0,125%
• sufentanil
sufentanil 1mcg/ml
• neurontin
gabapentin 600 mg pre-operative 3 dd 300 mg

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS score in rest		3 days after surgery	No
Secondary	Speed of mobilisation		3 days after surgery	No
Secondary	Postoperative morphine consumption	Daily morphine consumption (mg) per day	3 days after surgery	No
Secondary	NRS score during flexion exercise		3 days after surgery	No
Secondary	NRS score during walking exercise		3 days after surgery	No