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Completed

NCT Number: NCT03326999

Does Adding an Additional Numbing Medication Injection in the Thigh Help With Pain Control After Knee Replacement Surgery?

One common anesthetic that is performed for total knee replacement surgery is spinal anesthesia with an adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control after surgery. The aim of this study is to determine whether the addition of another regional block called obturator nerve block, which involves injecting numbing medication in the upper thigh region, will improve pain control after surgery while not sacrificing mobility after surgery.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Rheumatism Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

There is currently no consensus on the optimal strategy that provides the most effective postoperative analgesia while preserving ambulation and limiting side effects such as nausea and vomiting. The clinical team's hypothesis is that the obturator nerve block in addition to adductor canal block can target both the anterior and posterior distribution of nerves to the knee to provide superior analgesia while not limiting ambulation. To test this hypothesis, the clinical team will compare the rate of IV opioid consumption in patients who receive a combination of adductor canal block and obturator nerve block at the surgical site versus patients who receive adductor canal block alone.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled to undergo total knee arthroplasty
  • Planned use of regional anesthesia for procedure
  • Willing and able to provide informed consent

Exclusion criteria

  • Patients on immunosuppressive therapy
  • Patients with history of diabetes
  • Patients with lower limb neuropathy
  • Patients with history of chronic opioid use for > 3 months, including but not limited to, fentanyl, morphine, oxycodone, methadone
  • Patients with known allergy or intolerance to any drug used in the study
  • Patients with history of alcohol or drug abuse
  • Patients with history of intolerance of nonsteroidal anti-inflammatory drugs
  • Patients with hepatic or renal insufficiency
  • ASA score of 4 or greater

Treatment and study plan

Obturator nerve regional block

Drug

Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.

Other names: bupivacaine

Adductor canal regional block

Drug

Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.

Saline

Drug

Saline as placebo comparator

Primary outcomes

  1. Morphine Equivalence Consumption

    Time frame: up to 24 hours after surgery

    Total amount of opioids consumed

Secondary outcomes

  1. Pain Score

    Time frame: 1, 6, 12, and 24 hours after surgery

    Likert scale ranging from 0-10 - 0 being no pain, and 10 being the worst pain ever experienced

  2. Number of Participants With Nausea or Vomiting

    Time frame: up to 24 hours after surgery

    Yes or No responses when the subject is asked if the subject is feeling nauseous or has vomited

  3. Time to Ambulation

    Time frame: on postoperative day 1 after surgery

    The length of time that it takes before the patient is first able to walk with assistance after surgery as assessed by a physical therapist.

  4. Time to Breakthrough Pain Medication

    Time frame: up to post operative day 2 after surgery

    Time before pain medication needed for breakthrough pain

  5. Analgesia Satisfaction Score

    Time frame: 2 weeks after surgery

    Analgesia Satisfaction Score - Full scale from 0-10 with higher score indicating higher satisfaction.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Evaluating the Addition of Obturator Nerve Block to Adductor Canal Block for Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Sep 30, 2020

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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