Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143738
• Other study ID #: KE-0254/188/2016
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: July 26, 2018

Study information

• Verified date: February 2019
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.

All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.

The observed goals: pain intensity, the beginning and quality of rehabilitation.

Description:

Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.

The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.

All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 26, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• knee arthroplasty

• obtained consent

• subarachnoid anaesthesia

Exclusion Criteria:

• coagulopathy

• allergy to to local anesthetics

• depression, antidepressant drugs treatment

• epilepsy

• usage of painkiller before surgery

• addiction to alcohol or recreational drugs

Related Conditions & MeSH terms

• Acute Pain
• Joint Diseases
• Knee Arthropathy
• Mobility Limitation
• Pain, Acute
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• continuous anesthesia of adductor canal
After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
• continuous anesthesia of femoral nerve
After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
• Spinal anesthesia
Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.

Locations

Country	Name	City	State
Poland	Michal Borys	Lublin

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	Konskie Specjalist Hospital

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump	24 hours from the end of surgery
Secondary	Knee flexion	range of flexion in operated knee	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Secondary	Walking	Possibility of walking by patients at scheduled time points	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Secondary	The change of acute postoperative pain	Measured with VAS (visual-analogue scale)	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Secondary	Sitting	Possibility of walking by patients at scheduled time points	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)