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Completed

NCT Number: NCT02539628

Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for total knee arthroplasty in spinal anesthesia
  • Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
  • American society of anesthesiologists 1-3
  • Ability to perform a timed up and go test preoperatively

Exclusion criteria

  • Patients who cannot cooperate
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to the medicines used in the study
  • Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
  • Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
  • Rheumatoid arthritis
  • BMI > 40
  • Neuromuscular pathology in the lower limbs
  • Pregnancy

Treatment and study plan

Ropivacaine 0.2%

Drug

Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM

Primary outcomes

  1. Total opioid consumption

    Time frame: 2 days postoperative

    Difference in total opioid consumption (patient controlled analgesia pump and any potential rescue administration) between groups, from end of surgery until 12 pm on postoperative day (POD) 2.

Secondary outcomes

  1. Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)

    Time frame: 2 days postoepratively

    Visual analogue scale (VAS) pain scores (0-100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points (Day of surgery (DOS): 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).

  2. Pain at rest as assessed by the VAS pain scores

    Time frame: 2 days postoperatively

    VAS pain scores (0-100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points (DOS: 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).

  3. Pain during the Timed Up and Go test as assessed by the VAS

    Time frame: 1 and 2 days postoperatively

    Worst pain (VAS, 0-100 mm) during the Timed Up and Go test at 12 pm on POD 1 and 2.

  4. Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2

    Time frame: 1 and 2 days postoperatively

    Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2.

  5. Timed Up and Go test

    Time frame: 1 and 2 days postoperatively

    Time (seconds) to perform the Timed Up and Go test at 12 pm on POD 1 and 2.

  6. Number of patients able to perform the Timed Up and Go test

    Time frame: 1 and 2 days postoperatively

    Number of patients able to perform the Timed Up and Go test at 12 pm on POD 1 and 2.

  7. 6 min walk test

    Time frame: 1 and 2 days postoperativley

    Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.

Sponsors and collaborators

Lead sponsor

Pia Jaeger

Other

Collaborators

  • Bispebjerg Hospital
  • Smiths Medical, ASD, Inc.
  • University of California, San Diego

Registry information

Official study title

Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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