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

April 15, 2019 updated by: Reis Drudis, Institut de Recerca Biomèdica de Lleida
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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:

  1. To compare postoperative pain control effects between adductor canal block and placebo block.
  2. 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.
  3. To estimate variations in quadriceps and adductor muscle strength in the two groups of patients.
  4. To asses related side effects to adductor canal nerve block.
  5. 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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitary Santa Maria
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adductor Canal Block
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 .
Procedure: Single adductor canal block
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
PLACEBO_COMPARATOR: Placebo Comparator
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.
Procedure: Simulated adductor canal block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale
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.
Assessed using a Numerical Rating Scale (NRS) from 0 to 10
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 Measures

Outcome Measure
Measure Description
Time Frame
Knee extensor muscle strength
Time Frame: Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Measured using a hand-held dynamometer
Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Adductor muscle strength
Time Frame: Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Measured using a hand-held dynamometer
Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention
Ability to walk with ten meter walk test
Time Frame: First and second postoperative day every 12 hours
Measured with the ten meter walk test (TMWT)
First and second postoperative day every 12 hours
Rate of pain rescue treatments.
Time Frame: First 72 hours following surgery
Rate of intravenous opioid needed by the patients.
First 72 hours following surgery
Rate of opioid side effects.
Time Frame: First 72 hours following surgery
Rate of episodes of dizziness or nausea or vomit after opioid intake.
First 72 hours following surgery
Length of hospital stay
Time Frame: From date to operation until the data of discharge home, assessed up to 1 month
From date to operation until the data of discharge home, assessed up to 1 month
Rate of adductor canal block complications
Time Frame: First 72 hours following surgery
Including: local swelling, hematoma, vascular or neurological lesion and falls.
First 72 hours following surgery
Rate of surgery local complications
Time Frame: From date to operation until the data of discharge home, assessed up to 1 month
Including, hematoma, wound infection, arthroplasty infection, vascular or neurological lesion.
From date to operation until the data of discharge home, assessed up to 1 month
Rate of medical complications
Time Frame: From date to operation until the data of discharge home, assessed up to 1 month
Including neurological, cardiological, urological and respiratory.
From date to operation until the data of discharge home, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recerca Biomèdica de Lleida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2018

Primary Completion (ANTICIPATED)

September 2, 2019

Study Completion (ANTICIPATED)

September 2, 2019

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC-1806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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