Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength

NCT02007850 | Unknown

• 1 other identifier: B-1308/214-010
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Quadriceps muscle strength is an important determinant of quality of recovery in elderly patients after total knee arthroplasty. We try to compare the quadriceps muscle strength change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled femoral analgesia group.

Conditions

Muscle Weakness

Keywords

continuous femoral nerve block; knee arthroplasty; quadriceps muscle strength

Outcome Measures

Primary Outcomes (1)

• Change of quadriceps muscle strength

  maximum voluntary isometric contraction of quadriceps femoris with hand held manometry

  Baseline, Postoperative 2nd day

Secondary Outcomes (4)

• sensory changes in femoral nerve distribution

  postoperative 2 day

• pain scores

  postoperative 1 day

• pain scores

  postoperative 2 day

• intravenous fentanyl consumption

  postoperative 2 day

Study Arms (2)

ropivacaine continuous mode

PLACEBO COMPARATOR

0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl

Drug: ropivacaine

ropivacaine patient controlled mode

ACTIVE COMPARATOR

0.2% ropivacaine patient controlled mode, basal rate 4 ml/hr, bolus 4 ml, lockout 60 minutes through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl

Drug: ropivacaine

Interventions

ropivacaine DRUG

Patients receive 15 ml of 0.25% ropivacaine pre-operatively through femoral block catheter, followed by 0.2% ropivacaine continuous mode or patient controlled mode for 2 days after surgery

Also known as: femoral nerve block

ropivacaine continuous mode; ropivacaine patient controlled mode

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 21, or \< 80 years old- men and women
• primary, unilateral total knee replacement surgery
• spinal anesthesia

You may not qualify if:

• general anesthesia
• secondary knee replacement surgery
• patient refusal for continuous femoral nerve analgesia technique
• abnormal coagulation profile, e.g. Prothrombin time international normalized ratio \> 1.5, activated partial thrombin time \> 50 sec
• within 5 days after termination oral antiplatelet agent
• Body mass index\>45
• impaired renal function
• infection near femoral area
• previous injury near femoral area
• neurologic dysfunction in lower limb
• previous adverse drug reaction for local anesthetics
• American society of anesthesiologists (ASA) class III, iV or V

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Sungnam, Gyungido, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hae Wone Chang, M.D.

  Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hae Wone Chang, M.D

CONTACT

82-031-787-7499; chelenh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: December 11, 2013
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

KR (1)