Analgesia After Total Knee Replacement Surgery - Full Text View

Purpose

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.

Condition	Intervention
Total Knee Arthroplasty	Drug: naropin Drug: marcaine Drug: sufentanil Drug: neurontin


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Gabapentin Sufentanil citrate Ropivacaine monohydrochloride Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:

NRS score in rest [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Speed of mobilisation [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
Postoperative morphine consumption [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
Daily morphine consumption (mg) per day
NRS score during flexion exercise [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]
NRS score during walking exercise [ Time Frame: 3 days after surgery ] [ Designated as safety issue: No ]


Enrollment:	81
Study Start Date:	March 2013
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: epidural analgesia 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: marcaine bupivacaine 0,125% Other Name: bupivacaine Drug: sufentanil sufentanil 1mcg/ml Other Name: sufenta forte
Active Comparator: local infiltration The second group will receive local infiltration with ropivacaine of the knee during surgery.	Drug: naropin ropivacaine 0,2%, 3x 50 ml during surgery Other Name: ropivacaine
Active Comparator: local infiltration and gabapentin The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.	Drug: naropin ropivacaine 0,2%, 3x 50 ml during surgery Other Name: ropivacaine Drug: neurontin gabapentin 600 mg pre-operative 3 dd 300 mg Other Name: gabapentin

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489631

Locations


Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3430 EM

Sponsors and Collaborators

St. Antonius Hospital

Investigators


Principal Investigator:	Leon Timmerman, MD	Anesthesiologist
Principal Investigator:	Louis N Marting, MD	Orthopedic surgeon

More Information


Responsible Party:	Leon Timmerman, anesthesiologist, St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT01489631 History of Changes
Other Study ID Numbers:	TKP-37796
Study First Received:	December 8, 2011
Last Updated:	June 4, 2015
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:


Epidural Local infiltration Knee Arthroplasty

Additional relevant MeSH terms:


Gabapentin Sufentanil Bupivacaine Ropivacaine Gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents Analgesics, Opioid Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics

ClinicalTrials.gov processed this record on September 30, 2016