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A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02104934
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital

Brief Summary:

Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint.

Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness.

The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.


Condition or disease Intervention/treatment Phase
Analgesia in Total Knee Arthroplasty Procedure: Adductor Canal Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Local Infiltration Analgesia
The Local Infiltration Analgesia group will receive local infiltration of ropivacaine 150mg, ketorolac 30mg, morphine 10mg, adrenaline 200mcg and vancomycin 500mg in a total volume of 75mls by the surgeon.
Active Comparator: Adductor Canal Block
The Adductor Canal Block group of patients will receive intravenous ketorolac 30mg intra-operatively and an adductor canal block at the end of surgery. The block will be performed under real time ultrasound guidance and 30mls of 0.5% ropivacaine (150mg) is injected with a Stimuplex A100, 21G needle.
Procedure: Adductor Canal Block



Primary Outcome Measures :
  1. Morphine consumption in the first 24 hours [ Time Frame: 24 hours ]
    morphine consumption in the first 24 hours (including morphine administered in recovery and via PCA).


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 1, 6, 12, 24 hours; up to 48 hours postoperative ]
    Pain scores are recorded at 1, 6, 12, 24 and 48 hours post-operatively, assessed using a visual analog scale (0-100mm) at rest and during 45 degree passive flexion of knee.

  2. Morphine Consumption [ Time Frame: At 48 hours ]
    The balance usage after primary outcome

  3. Postoperative Nausea and Vomiting [ Time Frame: Up to 48 hours ]
    Presence/absence of nausea and vomiting, and total number of episodes of vomiting

  4. Sedation Scores [ Time Frame: Up to 48 hours ]
  5. Quadriceps Strength [ Time Frame: at 24 and 48 hours ]

Other Outcome Measures:
  1. Presence of Complications [ Time Frame: up to 48 hours ]
    Hematoma, wound infection, neurological deficits, any incidence of fall

  2. Length of Hospital Stay [ Time Frame: Up to 30 days ]
    Number of days till discharge



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2

Exclusion Criteria:

  • Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104934


Locations
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Singapore
Changi General Hospital
Singapore, Singapore
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: Yean Chin Lim, MBBS Changi General Hospital

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Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT02104934     History of Changes
Other Study ID Numbers: CGHLIAACB2013
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms