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Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

Primary Purpose

Total Knee Arthroplasty, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Single adductor canal block
Simulated adductor canal block
Sponsored by
Institut de Recerca Biomèdica de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring total kee arthroplasty, adductor canal block, multimodal analgesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing elective unilateral total knee arthroplasty
  • American Society of Anesthesiologist (ASA) class 1-3
  • Adults aged 18-85 years old

Exclusion Criteria:

  • Contraindications of the adductor canal block.
  • Contraindications of the local infiltration analgesia technique.
  • Chronic kidney disease
  • Surgery to be performed under general anesthesia.
  • Opioid treatment > 30 mgr morphine or equivalent for more than 3 months time.
  • Neuropathic ipsilateral pain.
  • Inability to understand study procedures.
  • Not acceptance of the procedure (adductor canal block or local infiltration analgesia).

Sites / Locations

  • Hospital Universitary Santa MariaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adductor Canal Block

Placebo Comparator

Arm Description

Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a single adductor canal block wiht 20cc of 0.5% Ropivacaine using ultrasound guidance .

Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a sham adductor canal block with 2ml of 1% subcutaneous lidocaine at the level of the adductor canal using ultrasound guidance.

Outcomes

Primary Outcome Measures

Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale
Assessed using a Numerical Rating Scale (NRS) from 0 to 10

Secondary Outcome Measures

Knee extensor muscle strength
Measured using a hand-held dynamometer
Adductor muscle strength
Measured using a hand-held dynamometer
Ability to walk with ten meter walk test
Measured with the ten meter walk test (TMWT)
Rate of pain rescue treatments.
Rate of intravenous opioid needed by the patients.
Rate of opioid side effects.
Rate of episodes of dizziness or nausea or vomit after opioid intake.
Length of hospital stay
Rate of adductor canal block complications
Including: local swelling, hematoma, vascular or neurological lesion and falls.
Rate of surgery local complications
Including, hematoma, wound infection, arthroplasty infection, vascular or neurological lesion.
Rate of medical complications
Including neurological, cardiological, urological and respiratory.

Full Information

First Posted
April 8, 2019
Last Updated
April 15, 2019
Sponsor
Institut de Recerca Biomèdica de Lleida
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1. Study Identification

Unique Protocol Identification Number
NCT03915522
Brief Title
Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty
Official Title
Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
September 2, 2019 (Anticipated)
Study Completion Date
September 2, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recerca Biomèdica de Lleida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effectivity of adductor canal block performed the day after total knee arthroplasty surgery in reducing pain and improving walking ambulation ability and muscle strength.
Detailed Description
Overview: total knee arthroplasty is a painful procedure. According to our institutional pain registers the worst pain appears in postoperative day one, which could be related to the use of effective but short analgesic intraoperative techniques like periarticular local analgesic infiltration and intravenous multimodal analgesia. The aim: to asses if adductor canal block performed the day after primary total knee arthroplasty (16-20 hours postoperative) improves analgesia without motor blockade and impairment of early ambulation ability. Primary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves postoperative analgesia. Secondary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves ability of early ambulation, adductor and quadriceps strength after primary total knee arthroplasty. The objectives: To compare postoperative pain control effects between adductor canal block and placebo block. To assess the improvement of ability of early ambulation and extent of motor blockade after primary total knee joint replacement surgery between the groups of patients. To estimate variations in quadriceps and adductor muscle strength in the two groups of patients. To asses related side effects to adductor canal nerve block. To asses variations in length of stay between the two groups. Methods: The prospective, double-blinded study includes American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment, aged 18-85 years, admitted for primary total knee arthroplasty. Preoperatively a simple randomization is made to distribute the included patients in two groups: Standard Group and Intervention Group. A table of random numbers is used, first selecting the starting point and later the movement direction remains constant throughout the whole table. The even numbers are allocated in the Standard Group and the odd ones in the Intervention group. The anesthesiologist performing the block will be aware of the treatment, but the participant subject and outcomes assessor will be blinded to the group assignment. During the perioperative period all patients from both groups will receive a standardized anesthetic and analgesic treatment: premedication with midazolam 2.5-5 mg and dexamethasone 0'1 mg/kg, spinal anesthesia with 10mg of hyperbaric bupivacaine and intravenous propofol during the surgery for sedation. As analgesia paracetamol 1gr plus dexketoprofen 50 mg. The local infiltration analgesia will be performed in a protocolized manner during the surgery with ropivacaine 0'2% 120 cc mixed with 0'6 mg adrenaline and at the end of surgery with ropivacaine 0'2% 40cc for subcutaneous infiltration. Two doses of 0'1mg/kg tranexamic acid are administrated unless contraindication, first one 30 min before skin incision and second one three hours later. Postoperative analgesia will be administrated to both groups of patients with ibuprofen 600 mg/8h and paracetamol 1gr/6h. Opioids will be available to patients as intravenous boluses of tramadol 1mg/kg if pain numerical rate score (NRS) > 3 at rest or > 5 at movement. All patients included in the study are transferred to post-anesthesia reanimation unit 16-20h after surgery, in postoperative day one. The operated extremity is slightly externally rotated and prepared for the block with 2% chlorhexidine and sterile dressing and the adductor canal is identified with ultrasound image at the mid-thigh level. In standard group patients a sham adductor canal block with 2ml of 1% subcutaneous lidocaine is done. In intervention group patients an adductor canal block with a 22 Gauge ultrasound-visible needle and 20 ml of 0'5% ropivacaine is done. At the end all patients have a sterile apposite on the puncture site. Postoperative pain will be assessed 15 minutes before the procedure (adductor or sham block), 2 hour, 24 hour post and also in the three nursing rounds (morning, afternoon, night) the first 72 hours after surgery. The pain numeric rating scale (NRS) is used (from 0 - no pain to 10 - worst imaginable pain) at rest and during active knee flexion. The requirement of additional opioids and their side effects (if any) will be recorded. Knee extensor and adductor muscle strength is measured using a hand-held dynamometer (Baseline Digital Hydraulic Push Pull Dynamometer R)) immediately prior to surgery, in first postoperative, day immediately before the procedure, 2 hours and 24 hour postprocedure. Patients ability of early ambulation is evaluated using ten meter walk test (TMWT) in the first and second postoperative day every 12h. The success rate of the block is assessed by testing for sensation of cold and pinprick stimulus at the medial midcalf using a 3-point scale (2 = normal sensation, 1 = decreased sensation, 0 = no sensation) 2 hours after block. The length of hospital stay and rate of complications (if any), will be recorded in both groups of patients. Complications will be graded as local complications (hematoma, wound complications…), block complications (falls, vascular injection…), urinary complications (acute urine retention, renal failure…) and general complications (neurological, respiratory, cardiological…). According to study protocol, both groups of patients will be compared in terms of postoperative pain control, opioid consumption, postoperative nausea and vomiting, quadriceps strength, adductor strength, ability of early ambulation, length of hospitalization and complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Knee Osteoarthritis
Keywords
total kee arthroplasty, adductor canal block, multimodal analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A simple randomization is made to distribute the included patients in two groups: Standard Group and Intervention Group. A table of random numbers is used, first selecting the starting point and later the movement direction remains constant throughout the whole table. The even numbers are allocated in the standard group and the odd ones in the intervention group.
Masking
ParticipantOutcomes Assessor
Masking Description
All patients included in the study are transferred the day after the total knee arthroplasty surgery to the postoperative resuscitation unit. A sterile dressing of the lower extremity is performed and after the adductor canal is identified with ultrasound image, a medial leg puncture is done with or without doing the canal adductor block. At the end all patients have a sterile apposite on the puncture site. All variables and outcomes are collected and registered by people not involved in the realization of the intervention.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Block
Arm Type
Experimental
Arm Description
Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a single adductor canal block wiht 20cc of 0.5% Ropivacaine using ultrasound guidance .
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Patients will receive multi-modal analgesia (oral, intravenous and local infiltration anesthesia) for pain management following total knee arthroplasty and in the first postoperative day a sham adductor canal block with 2ml of 1% subcutaneous lidocaine at the level of the adductor canal using ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
Single adductor canal block
Intervention Description
The operated leg is slightly externally rotated and prepared for a block with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and after a subcutaneous injection of 2 ml of 1% lidocaine a total of 20 ml of 0'5% ropivacaine is injected into the canal using a 22 gauge ultrasound-visible needle. In the end, a sterile apposite is placed at the puncture site
Intervention Type
Procedure
Intervention Name(s)
Simulated adductor canal block
Intervention Description
The operated leg is slightly externally rotated and prepared with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and at this leve a subcutaneous injection of 2 ml of 1% lidocaine . After, a sterile apposite is placed at the puncture site.
Primary Outcome Measure Information:
Title
Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale
Description
Assessed using a Numerical Rating Scale (NRS) from 0 to 10
Time Frame
Registered immediately prior to surgery, first postoperative day immediately prior to procedure, 2 hours postprocedure and every 8 hours the first three days in the orthopedic ward.
Secondary Outcome Measure Information:
Title
Knee extensor muscle strength
Description
Measured using a hand-held dynamometer
Time Frame
Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Title
Adductor muscle strength
Description
Measured using a hand-held dynamometer
Time Frame
Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Title
Ability to walk with ten meter walk test
Description
Measured with the ten meter walk test (TMWT)
Time Frame
First and second postoperative day every 12 hours
Title
Rate of pain rescue treatments.
Description
Rate of intravenous opioid needed by the patients.
Time Frame
First 72 hours following surgery
Title
Rate of opioid side effects.
Description
Rate of episodes of dizziness or nausea or vomit after opioid intake.
Time Frame
First 72 hours following surgery
Title
Length of hospital stay
Time Frame
From date to operation until the data of discharge home, assessed up to 1 month
Title
Rate of adductor canal block complications
Description
Including: local swelling, hematoma, vascular or neurological lesion and falls.
Time Frame
First 72 hours following surgery
Title
Rate of surgery local complications
Description
Including, hematoma, wound infection, arthroplasty infection, vascular or neurological lesion.
Time Frame
From date to operation until the data of discharge home, assessed up to 1 month
Title
Rate of medical complications
Description
Including neurological, cardiological, urological and respiratory.
Time Frame
From date to operation until the data of discharge home, assessed up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing elective unilateral total knee arthroplasty American Society of Anesthesiologist (ASA) class 1-3 Adults aged 18-85 years old Exclusion Criteria: Contraindications of the adductor canal block. Contraindications of the local infiltration analgesia technique. Chronic kidney disease Surgery to be performed under general anesthesia. Opioid treatment > 30 mgr morphine or equivalent for more than 3 months time. Neuropathic ipsilateral pain. Inability to understand study procedures. Not acceptance of the procedure (adductor canal block or local infiltration analgesia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reis Drudis Morell, MD
Phone
34630011138
Email
reisdrudis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Colomina Morales, MD
Phone
34 679513862
Email
jordicolomina82@gmail.com
Facility Information:
Facility Name
Hospital Universitary Santa Maria
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reis Drudis Morell, MD
Phone
34 630011138
Email
reisdrudis@gmail.com
First Name & Middle Initial & Last Name & Degree
Jordi Colomina Morales, MD
Phone
34 679513862
Email
jordicolomina82@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty

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