Evaluation of a Fast-track Knee Arthroplasty Concept

Postoperative Pain Clinical Trial

— KneeOptOut  

Official title:

Implementation of a Fast-track Knee Arthroplasty Concept: a Randomized, Controlled, Open Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114306
• Other study ID #: KneeOptOut
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mobilisation following knee arthroplasty is an important aspect to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. This RCT evaluates two analgetic regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Description:

Mobilisation following knee arthroplasty is important for patients to achieve early and enhanced recovery after surgery and sufficient joint function. Analgesia is a crucial therapeutic element in this context. There is evidence that regional- anaesthesiological catheter techniques are very efficient to control pain postoperatively. On the other hand, motoric function may be reduced due to nerve blocks depending on location and concentration of drug used. Local infiltration of the knee during surgery is an alternative component in pain management that may reduce impaired motor function and allow early mobilisation of patients. However, currently it is not known which analgesia technique provides optimal pain control paralleled with sufficient motor function. Against this background, this RCT evaluates two analgesia regimens for patients undergoing primary total knee-replacement to assess impact on postoperative recovery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing elective, primary knee joint replacement in combined general anaesthesia

Exclusion Criteria:

• heart insufficiency NYHA >2
• liver insufficiency > CHILD B
• evidence of diabetic polyneuropathy
• severe adipositas BMI >40
• patients < 18 years
• pregnancy
• in case of police custody
• participation in a paralleled interventional RCT in a time frame of 30 days
• chronic opioid therapy >3 months before scheduled surgery
• allergy against medication required for surgery or anaesthesia

Related Conditions & MeSH terms

• Knee Arthropathy
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• local infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
• regional-anaesthesiological catheter analgesia
Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.

Locations

Country	Name	City	State
Germany	Charité University Berlin (CCM)	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Borck M, Wandrey JD, Hoft M, Kastelik J, Perka C, Tafelski S, Treskatsch S. Local infiltration analgesia versus peripheral nerve block anaesthesia in total knee arthroplasty: a pharmaco-economic comparison. BMC Anesthesiol. 2022 Mar 25;22(1):80. doi: 10.1 — View Citation

Kastelik J, Fuchs M, Kramer M, Trauzeddel RF, Ertmer M, von Roth P, Perka C, Kirschbaum SM, Tafelski S, Treskatsch S. Local infiltration anaesthesia versus sciatic nerve and adductor canal block for fast-track knee arthroplasty: A randomised controlled cl — View Citation

Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017. — View Citation

Rostlund T, Kehlet H. High-dose local infiltration analgesia after hip and knee replacement--what is it, why does it work, and what are the future challenges? Acta Orthop. 2007 Apr;78(2):159-61. doi: 10.1080/17453670710013627. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first mobilisation (standing)	time from end of surgery until patients is able to stand	up to 48h postoperatively
Secondary	patients satisfaction (11-point likert scale)	global satisfaction of patients	up to 7 days postoperatively
Secondary	time to first mobilisation (walking)	time from end of surgery until patients is able to walk	up to 7 days postoperatively
Secondary	complications	complications during perioperative care process (e.g. thrombosis, re-operation, infection)	up to 7 days postoperatively
Secondary	time to achieve full joint mobility	time to achieve full joint mobility (0/0/90°)	up to 7 days postoperatively
Secondary	pain intensity of patients (11-point likert visual analogue scale) measured 3 times daily (mean)	mean pain intensity of patients	up to 7 days postoperatively
Secondary	rescue pain medication	number of patients requiring rescue pain medication	up to 7 days postoperatively
Secondary	pain medication perioperatively	pain medication perioperatively (e.g. NSAIDs, opioids, con-analgetics)	up to 7 days postoperatively
Secondary	time to discharge	time to discharge from hospital	up to 14 days postoperatively