Randomized Controlled Trial of Total Knee Replacement Postoperative Analgesia Using Combined Continuous Adductor Canal Block and Single Shot Tibial Nerve Block vs Periarticular Infiltration in Chinese Population

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Queen Elizabeth Hospital, Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr Hui Kit Man Grace, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01973530
First received: October 25, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

We hypothesize continuous adductor canal block with single shot tibial nerve block would offer better anaglesics with rehabilitation ability for postoperative patients receiving total knee arthroplasty.


Condition Intervention Phase
Focus on Analgesic Efficacy and Rehabilitation Profile of Patients Receiving Two Types of Pain Interventions for Postop Pain After Total Knee Arthroplasty
Procedure: adductor canal block and tibial nerve block
Procedure: periarticular infiltration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Project Title: Randomized Controlled Trial of Total Knee Replacement Postoperative Analgesia Using Combined Continuous Adductor Canal Block and Single Shot Tibial Nerve Block vs Periarticular Infiltration in Chinese Population

Resource links provided by NLM:


Further study details as provided by Queen Elizabeth Hospital, Hong Kong:

Primary Outcome Measures:
  • PCA morphine or pain rescuer consumption at 24h and 48h postop [ Time Frame: 24h and 48h postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postop pain score (visual analogue scale 0-10) at 6h,12h, 24h,48h, 72h after surgery [ Time Frame: 6h, 12h, 24h, 48h postop ] [ Designated as safety issue: No ]
  • Active range of motion at 24h, 48h, 72h postop [ Time Frame: 24h, 48h, 72h postop ] [ Designated as safety issue: No ]
  • Quadriceps strength of operated leg at 24h, 48h, 72h postop [ Time Frame: 24h, 48h, 72h postop ] [ Designated as safety issue: No ]
  • Patient satisfaction score (0-4) [ Time Frame: upon discharge ] [ Designated as safety issue: No ]
  • Incidence of side effects and complications at postop day 0- 96h postop [ Time Frame: postoperative period 0-96 hr postop ] [ Designated as safety issue: Yes ]
  • Length of Stay in hospital 6. Length of Stay in hospital length of hospital stay [ Time Frame: upon discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: adductor canal block with tibial nerve block
Continuous adductor canal block and single shot posterior tibial nerve block (bolus: 0.5% Ropivacaine 20ml ; infusion of 0.2% Ropivacaine at 6ml/h) with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine)
Procedure: adductor canal block and tibial nerve block
periarticular infiltration
periarticular infiltration with ropivacaine, ketorolac and epinenephrine (total 50ml 0.2% ropivacaine with 20mg ketorolac and epinephrine 5mcg/ml for anterior and posterior structures infiltrations; 25ml 0.2% ropivacaine with ketorolac 10mg for subcutaneous infiltration) .
Procedure: periarticular infiltration

Detailed Description:

Method:

A total of 60 patients who will undergo total knee arthroplasty will be randomized into two groups:

Treatment groups Treatment details Group A Continuous adductor canal block and single shot posterior tibial nerve block (bolus: 0.5% Ropivacaine 20ml ; infusion of 0.2% Ropivacaine at 6ml/h) with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine) Group B periarticular infiltration with ropivacaine, ketorolac and epinenephrine (total 50ml 0.2% ropivacaine with 20mg ketorolac and epinephrine 5mcg/ml for anterior and posterior structures infiltrations; 25ml 0.2% ropivacaine with ketorolac 10mg for subcutaneous infiltration) .

Two groups will receive the same preemptive and postoperative multimodal regime for perioperative analgesia. All groups will receive standardized method of spinal anaesthesia for surgery.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Diagnosis of primary osteoarthritis

    • Scheduled for elective total knee arthroplasty
    • Signed written informed consent
    • Planned use of spinal anaesthesia
    • Cognitive sound to use assessment tools

Exclusion Criteria:

  • • Patients refusing to give consents

    • Cognitive impairment/ inability to use the outcome assessment tools
    • Contraindications to regional anesthesia
    • severe cardiovascular disease (unstable angina, second or third degree heart block)
    • pre-existing neurologic disease including psychiatric disorder
    • drug abuser
    • Pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
    • Allergy or contraindication to drugs used in this study: morphine, NSAID (ketorolac , diclofenac), dihydrocodeine, local anaesthetics (lignoacaine, ropicavaine, bupivacaine), epinenephrine
    • Moderate or severe renal impairment (serum creatinine > 160 micromol/l)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973530

Contacts
Contact: Grace Hui, MBBS FHKAM FHKCA 29586202 huikmg@ha.org.hk

Sponsors and Collaborators
Queen Elizabeth Hospital, Hong Kong
  More Information

No publications provided

Responsible Party: Dr Hui Kit Man Grace, Associate Consultant, Dept of Anaesthesia and Operating Services, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT01973530     History of Changes
Other Study ID Numbers: BHJRC_HK_TKR_Study_2014
Study First Received: October 25, 2013
Last Updated: October 30, 2013
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014